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Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Head of Value, Access & Pricing Europe Open Commercial Zug, Switzerland Zug CHE Apr 25th, 2019 12:00AM Summary: In this role, you will lead development of the European Market Access strategy for the company’s oncology pipeline. Specifically, the Head EU Value Access & Pricing will lead efforts in assessing and communicating to internal and external stakeholders the market access requirements of Europe for oncology, contributing to and shaping the overall value strategy for our brands throughout lifecycle. The position will build and support country value access teams in the preparation and delivery of HTA submissions, P&R negotiations, and will be responsible for helping translate relevant developments into meaningful guidance and strategic advice. Responsibilities: Identify, analyze, develop, and implement recommendations and strategies regarding P&R policy and challenges important to company’s product portfolioAnalyze, synthesize, and translate technical P&R information, including coverage and reimbursement policies, into meaningful decision points, recommendations, and strategic tacticsChampion the P&R requirements for Europe Commercial Operations throughout commercialization and ensure alignment between all stakeholders internally as to prioritized needs;Contribute to strategy discussions and communication efforts with relevant external stakeholders including key government agencies and organizations;Design and build the EU Value Access and Pricing organization in close partnership with Head of EU Commercial Operations and VP Global Value Access and Pricing, defining EU specific needs and requirements and organizational capabilities to ensure optimal pricing and market access for emerging portfolio;Partner in development of global value access & pricing deliverables, working in close collaboration with global colleagues and external vendorsLead development of EU market access deliverables including HTA submissions; negotiation strategies, and country-level regional and local market access tactics to secure reimbursement;Develop HTA payer engagement plans and sort early scientific advice from HTA agencies and other external experts;Incorporate and develop strategy for Patient Access programs;Establish EU pricing operations including governance and launch sequencingCollaborate closely with relevant internal stakeholders, including Marketing, Medical Affairs, Regulatory, etc. Qualifications: Degree in Health Economics, Health Research, Pharmacy or a relevant related discipline10+ years of experience within the field of Market Access, Health Economics, Outcomes ResearchStrong oncology market knowledge from a commercial and clinical studies perspectiveTeam leader and a hands on project leader with entrepreneurial spirit and desire to build a team and capabilityExcellent communication and negotiation skillsBusiness fluency in English As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Manufacturing Manager / Manufacturing Scientist Open Manufacturing & Supply Chain Zug, Switzerland Zug CHE Apr 15th, 2019 12:00AM Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. We are currently seeking a Manufacturing Manager to join the External Manufacturing & Supply Operations team based in our EU subsidiary site in Zug, Switzerland.  The position will support production efforts at Contract Manufacturing Organizations (CMOs) throughout Europe, with an emphasis on oral solid dosage manufacturing.   Responsibilities:Develop expertise in manufacturing processes and provide technical input to internal development teams and CMOs.Participate in multi-functional project teams during technology transfer and manufacturing stages of projects.Facilitate internal and external discussions to identify, address, or escalate (as needed) technical or business challenges, disputes, and questionsDevelop strong technical and business relationships with CMOs and serve as an advocate for the organization’s interests.Provide onsite oversight for small molecule manufacturing at CMOs to ensure overall compliance, appropriate resolution to critical issues, and timely progress updates.Support process changes and continuous improvement efforts by application of facility fit, equipment know-how, and novel manufacturing technologies.Perform technical review of master and executed batch records, specifications, deviations, and change requests and manage timely implementation of such documents to meet project timelines.Develop, monitor, and maintain positive business relationships with CMOs and partners to encourage collaboration, improvements, transparency, and accountability. QualificationsDegree in chemistry or other Life Science with 7+ years relevant experience in biotechnology or pharmaceutical industry.Extensive oral solid dosage process knowledge including proficiency with solid dose equipment, experience with product scale-up and technology transfer. Experience with Spray-Dried Dispersion (SDD) technology desirable.Demonstrated proficiency in small molecule manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practices.Experience working with CMOs on a broad range of projects including support of commercial and/or clinical manufacturing in a GMP environment.Experience working in global project teams, leading and motivating cross functional teams in a matrix management environment.Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Sr. QC Manager, External Manufacturing Europe Open Quality Zug, Switzerland Zug CHE Mar 25th, 2019 12:00AM Summary:The Sr. QC Manager will act as a single point of contact and SME for testing activities at CLTs and CMOs across Europe - partnering with Seagen's European Quality and Manufacturing team, US HQ stakeholders and external vendors to address all QC needs for Europe. The Sr. QC Manager may also act as a deputy to the Associate Director of Quality, Europe, and provide mentoring and supervision as required   Responsibilities: Serve as the single point of contact and subject matter expert for all testing activities at Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs) in Europe for commercial large and small molecule products (starting materials, API, Intermediates, and Drug Product)Develop and maintain positive relationships with CTLs/CMOs to encourage collaboration, improvement, transparency, and accountabilityApprove specifications, test methods, and stability protocolsReview release and stability data.  Approve CoAsManage deviations, laboratory investigations, OOS, and changes per SeaGen procedures and Quality AgreementsTroubleshoot and direct the resolution of quality and technical issuesOversee method transfer and method validation activities and review protocols and reportsPeriodically assess and confirm compliance levels at contract test labs (confirming standard laboratory practices are in a good state of control and in conformance with regional and international standards)Provides input to and gathers information for the strategic management of the product testing “footprint” for SeaGen products. Make recommendations to initiate or terminate contracts with testing labsAssists in method trending if methods are performed in multiple labsAssists in managing critical reagent and reference standard inventory at contract test labsDevelop Quality Agreements and monitor compliance once approvedCollaborate with CTLs/CMOs and corporate HQ on performance metrics, process monitoring, assay monitoring, and product quality reviews.Collaborate with CTLs/CMOs on preparation for health authority inspections and provides on-site support during inspections as neededThe incumbent will act as a deputy to the Associate Director of Quality Assurance and provide mentoring and supervision as required  Qualifications:Bachelor’s degree in a scientific discipline (chemistry or biology focus preferred) or other relevant degree10+ years of experience in a QC or analytical laboratory Leadership experience is a plus Knowledge of small molecule synthetic and analytical chemistry as well as the analytics required for monoclonal antibodies and other protein therapeutics in order to contribute meaningfully to data review, investigations, study design and report-reviewKnowledge of regional and international testing requirements with experience developing strategies for testing release and stability of pharmaceutical productsExperience reviewing analytical data for compliance with GMPsExperience working with CMOs and CTLsExcellent communication skills and proven ability to work well with internal and external teams.  Experience with virtual teams or multi-site organizations preferred.Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solvingFluency in spoken and written EnglishAbility to travel within Europe (up to 50%) as well as occasional travel to the Corporate HQ in the US Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Regulatory Operations Specialist Open Regulatory Affairs Zug, Switzerland Zug CHE Apr 17th, 2019 12:00AM Summary:Responsible for managing publishing and electronic submissions in electronic Common Technical Document (eCTD) and paper format activities for the assigned product(s) in Europe, including pre- and post-marketing authorization applications. In addition, key responsibilities include operational and compliance support for the European regulatory science team. Will also assist in the publishing activities for product(s) in the US and Canada. Responsibilities:Manage (by European or Global Regulatory Operations) the electronic publishing of regulatory submission documents according to ICH, Competent Authority and company defined standards (CTA, MAA, eCTD, etc.) in compliance with technical validation requirements and in accordance with agreed timelines for regulatory submissions in the assigned regionsResponsible for regulatory publishing activities of assigned products for FDA and Health Canada submissionsEnsure tracking of reporting obligations in the RIMS system and proactively inform the Regulatory Liaison team of upcoming submissionsAssists submission authors and regulatory liaisons in the planning and preparation of regulatory submissions; when appropriate, composes regulatory forms, correspondence, and textAssists in the development of and implements documentation standards, templates, and procedures related to the formatting, publishing, and archiving of both electronic (eCTD) and paper submissionsMay participate on project teams as appropriate for assigned projects and/or submissionsMay assist in the evaluation, implementation, testing, and administration of Regulatory systems, including databases, documentation management systems, and publishing technologies for regulatory submissionsKeeps abreast with developments of electronic submission requirements in Europe and may take a leading role in their implementationFoster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvementQualifications:1-2+ years of experience in Regulatory Operations in the pharmaceutical/biotechnology industry, including experience in submitting initial or supplemental sequences to the EMA.Proficiency in Microsoft Office and Adobe Acrobat software requiredWorking knowledge of eCTD format and European submission requirementsExperience with eCTD publishing software preferableFamiliarity with technologies (e.g., eCTD systems, ESG, XML) to support electronic submissions and labeling preferableFluent in EnglishStrong communications and teamwork skills required. Attention to detail a mustAbility to multitask and switch gears quickly Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seattle Genetics, please visit www.seattlegenetics.com. Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Principal Statistical Programmer Open Biometrics South San Francisco, CA, United States South San Francisco CA USA Mar 1st, 2019 12:00AM Summary: The Principal Statistical Programmer provides programming expertise in support of the clinical development process.  This includes developing SAS programs to monitor, analyze, and report clinical trial data and managing programming activities and deliverables for contract programmers and external vendors.  Acts as a liaison between data management, biostatistics, and clinical operations as needed.  . The primary focus is to ensure that product and study level deliverables are completed on time, of high quality, and in accordance with company, industry, and regulatory requirements. The secondary focus is to engage in the enhancement clinical programming processes and infrastructure. Responsibilities: Develops SAS programs to analyze and report clinical trial data for CSRs, annual reports, regulatory submissions and publications with a focus on accuracy, completeness, quality, and timely deliveryManages programming activities and deliverables for contract SAS programmers and external vendors.  Ensuring programming is conducted according to departmental and industry standardsDevelops and maintains standard SAS macros, templates, and programming standards for biometrics departmentDevelops and maintains CDISC-compliant SDTM and ADaM data set specifications for clinical studiesPrograms CDISC-compliant SDTM and ADaM data sets for clinical studiesParticipates in the review of statistical analysis plans, study CRFs, edit check specifications, and database design specificationsPrograms SAS edit checks to assist data management’s data cleaning activitiesContributing to the development of departmental utilities, processes, procedures, and statistical computing environmentAssists in the preparation of NDAs/BLAsAssists in the development and writing of departmental SOPsProvide technical support and guidance to more junior programmers when requiredPerforms other responsibilities as assigned Qualifications: Ten or more years of relevant experience, including experience in the pharmaceutical or life sciences industryKnowledge of FDA regulatory requirements and ICH/GCP guidelines preferredExpertise with CDISC standardsDemonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferredExcellent knowledge of SAS programming and applications in the pharmaceuticals industry and clinical trial data setting is requiredDemonstrated understanding of and experience with clinical trial data and data manipulations, analysis and reporting of analysis resultsExcellent application development skills requiredExcellent overall computer proficiency required (PC-Windows preferred) and proficiency in Microsoft Word, Excel, PowerPoint, and SharepointClear and concise verbal and written communication skillsDetail oriented with excellent analytical and problem-solving skillsAbility to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environmentAbility to work independently and in a highly collaborative team environmentDedication to quality and reliability in all work tasksSelf-motivated, eagerness to grow professionally and commitment to self-development Preferred: Experience with oncology clinical studiesExperience with additional programming languages and tools such as R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS Education: Bachelor's or higher degree in a computer science, mathematics, statistics, or health-related field (or equivalent)BS and 8+ years or MS/PhD and 6+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries. Degree in computer science, mathematics, statistics, or health-related field As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Principal Statistical Programmer Open Biometrics Bothell, WA, United States Bothell WA USA Mar 1st, 2019 12:00AM Summary: The Principal Statistical Programmer provides programming expertise in support of the clinical development process.  This includes developing SAS programs to monitor, analyze, and report clinical trial data and managing programming activities and deliverables for contract programmers and external vendors.  Acts as a liaison between data management, biostatistics, and clinical operations as needed.  . The primary focus is to ensure that product and study level deliverables are completed on time, of high quality, and in accordance with company, industry, and regulatory requirements. The secondary focus is to engage in the enhancement clinical programming processes and infrastructure. Responsibilities: Develops SAS programs to analyze and report clinical trial data for CSRs, annual reports, regulatory submissions and publications with a focus on accuracy, completeness, quality, and timely deliveryManages programming activities and deliverables for contract SAS programmers and external vendors.  Ensuring programming is conducted according to departmental and industry standardsDevelops and maintains standard SAS macros, templates, and programming standards for biometrics departmentDevelops and maintains CDISC-compliant SDTM and ADaM data set specifications for clinical studiesPrograms CDISC-compliant SDTM and ADaM data sets for clinical studiesParticipates in the review of statistical analysis plans, study CRFs, edit check specifications, and database design specificationsPrograms SAS edit checks to assist data management’s data cleaning activitiesContributing to the development of departmental utilities, processes, procedures, and statistical computing environmentAssists in the preparation of NDAs/BLAsAssists in the development and writing of departmental SOPsProvide technical support and guidance to more junior programmers when requiredPerforms other responsibilities as assigned Qualifications: Ten or more years of relevant experience, including experience in the pharmaceutical or life sciences industryKnowledge of FDA regulatory requirements and ICH/GCP guidelines preferredExpertise with CDISC standardsDemonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferredExcellent knowledge of SAS programming and applications in the pharmaceuticals industry and clinical trial data setting is requiredDemonstrated understanding of and experience with clinical trial data and data manipulations, analysis and reporting of analysis resultsExcellent application development skills requiredExcellent overall computer proficiency required (PC-Windows preferred) and proficiency in Microsoft Word, Excel, PowerPoint, and SharepointClear and concise verbal and written communication skillsDetail oriented with excellent analytical and problem-solving skillsAbility to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environmentAbility to work independently and in a highly collaborative team environmentDedication to quality and reliability in all work tasksSelf-motivated, eagerness to grow professionally and commitment to self-development Preferred: Experience with oncology clinical studiesExperience with additional programming languages and tools such as R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS Education: Bachelor's or higher degree in a computer science, mathematics, statistics, or health-related field (or equivalent)BS and 8+ years or MS/PhD and 6+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries. Degree in computer science, mathematics, statistics, or health-related field As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Principal Biostatistician Open Biometrics South San Francisco, CA, United States South San Francisco CA USA May 3rd, 2019 12:00AM Summary:Provide statistical/strategic inputs to the clinical development plans while supporting clinical trials within a program. Key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community. Ensure adherence to regulatory and company standards. Responsibilities:Provide leadership to the Biometrics team on one or more clinical programs or key studies; review work of statisticians supporting this workProvide update to management on program progress with focus on BiometricsCollaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designsPerform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a designProvide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirementsDesign and write statistical sections for clinical trial protocols or oversee this workGenerate study randomizations and provide inputs on maintaining study blindingDevelop statistical analysis plans for clinical trials or oversee this workWrite statistical sections of regulatory submissions or oversee this workDesign and conduct statistical analysis of clinical data or oversee this workWork with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staffRepresent Seattle Genetics statistical position to regulatory agenciesKey contributor in project planningKeep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetingsBecome knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.Knowledge of FDA regulations, ICH GCP guidelines, the drug development process Qualifications:MS with 6+ years or PhD with 4+ years of experience as a study statistician with high independence on complicated studiesPrevious experience providing leadership to Biometrics staff within a clinical teamKnowledge and experience to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians.Excellent communication and presentation skills, both written and verbalKnowledge of FDA regulations, ICH guidelines, the drug development processProficiency with SAS® procedures and programming language Preferred:Submission experience a plusStrong simulations experience/skillsOncology experience preferredProficiency with S-Plus or R a benefitAs the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com. Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Sr. Biostatistician II Open Biometrics Bothell, WA, United States Bothell WA USA May 3rd, 2019 12:00AM Independently serve as clinical study statistician on multiple projects with limited supervision. Provide expertise in the design and development of study protocols and case report forms. Develop statistical analysis plans, perform statistical analyses, and interpret results. Develop SAS programs of varying complexity to analyze and report clinical data. Review programming specifications and outputs. Recognize inconsistencies and initiate resolution of data problems. Collaborate in the preparation and review of clinical study reports. Ensure adherence to regulatory and company standards. Responsibilities:Perform duties of a study statistician to support clinical trials. Oversee statistical aspects in the design of clinical trialsProvide statistical input to study protocolsPerform sample size and power calculationsReview CRFs and edit checksDevelop SAP and create table, listing, and figure shellsReview programming specifications and derived datasetsPerform or review statistical analysis as defined in SAPCode complex statistical analyses as neededInterpret results and write sections of documents; present resultsSupport program lead statisticians in preparations for interactions with regulatory agenciesRead and understand medical/clinical literature as required by dutiesDevelop and assist in maintenance of department tools, templates, guidelines, SOPs, and systemsWorking knowledge of FDA regulations, ICH GCP guidelines, the drug development processWork on problems of diverse scope in which analysis of data requires evaluation of identifiable factorsExercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions Qualifications:MS in statistics, biostatistics, or related field with 4-7 years of experience, or PhD with 2-5 years of experienceStrong SAS programming skillsWorking knowledge of clinical trial designKnowledge of FDA regulations, ICH GCP guidelines, the drug development processExcellent verbal and written communication skillsDemonstrated initiative and motivationGood organizational skills with the ability to adapt and adjust to changing prioritiesExperience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are requiredAble to prioritize work and complete deliverables to timelines with limited supervisionDetail and process oriented Preferred:Oncology experience preferredKnowledge of RSimulation experienceAs the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com. Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Principal Biostatistician Open Biometrics Bothell, WA, United States Bothell WA USA May 3rd, 2019 12:00AM Summary:Provide statistical/strategic inputs to the clinical development plans while supporting clinical trials within a program. Key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community. Ensure adherence to regulatory and company standards. Responsibilities:Provide leadership to the Biometrics team on one or more clinical programs or key studies; review work of statisticians supporting this workProvide update to management on program progress with focus on BiometricsCollaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designsPerform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a designProvide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirementsDesign and write statistical sections for clinical trial protocols or oversee this workGenerate study randomizations and provide inputs on maintaining study blindingDevelop statistical analysis plans for clinical trials or oversee this workWrite statistical sections of regulatory submissions or oversee this workDesign and conduct statistical analysis of clinical data or oversee this workWork with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staffRepresent Seattle Genetics statistical position to regulatory agenciesKey contributor in project planningKeep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetingsBecome knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.Knowledge of FDA regulations, ICH GCP guidelines, the drug development process Qualifications:MS with 6+ years or PhD with 4+ years of experience as a study statistician with high independence on complicated studiesPrevious experience providing leadership to Biometrics staff within a clinical teamKnowledge and experience to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians.Excellent communication and presentation skills, both written and verbalKnowledge of FDA regulations, ICH guidelines, the drug development processProficiency with SAS® procedures and programming language Preferred:Submission experience a plusStrong simulations experience/skillsOncology experience preferredProficiency with S-Plus or R a benefit As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com. Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology
nasdaq:sgen www.seattlegenetics.com www.seattlegenetics.com Jun 8th, 2019 12:00AM Principal Biostatistician Open Biometrics Seattle, WA, United States Seattle WA USA May 3rd, 2019 12:00AM Summary:Provide statistical/strategic inputs to the clinical development plans while supporting clinical trials within a program. Key contributor to clinical protocols for statistical concept as well as broader drug development concepts. Perform or oversee the analysis of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and scientific community. Ensure adherence to regulatory and company standards. Responsibilities:Provide leadership to the Biometrics team on one or more clinical programs or key studies; review work of statisticians supporting this workProvide update to management on program progress with focus on BiometricsCollaborate with medical monitors and other study personnel on the creation of clinical development plans and clinical trial designsPerform or oversee power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of a designProvide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirementsDesign and write statistical sections for clinical trial protocols or oversee this workGenerate study randomizations and provide inputs on maintaining study blindingDevelop statistical analysis plans for clinical trials or oversee this workWrite statistical sections of regulatory submissions or oversee this workDesign and conduct statistical analysis of clinical data or oversee this workWork with medical monitors to develop ad hoc analysis plans and ensure analyses are performed appropriately by programming staffRepresent Seattle Genetics statistical position to regulatory agenciesKey contributor in project planningKeep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetingsBecome knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.Knowledge of FDA regulations, ICH GCP guidelines, the drug development process Qualifications:MS with 6+ years or PhD with 4+ years of experience as a study statistician with high independence on complicated studiesPrevious experience providing leadership to Biometrics staff within a clinical teamKnowledge and experience to exercise independent judgment and provide oversight to programmers, data managers, and junior statisticians.Excellent communication and presentation skills, both written and verbalKnowledge of FDA regulations, ICH guidelines, the drug development processProficiency with SAS® procedures and programming language Preferred:Submission experience a plusStrong simulations experience/skillsOncology experience preferredProficiency with S-Plus or R a benefit As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com. Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Jun 8th, 2019 01:19PM Jun 8th, 2019 01:19PM Health Care Pharmaceuticals & Biotechnology

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