Manager, Statistical Programming

Fiveprime Therapeutics, Inc. South San Francisco , CA 94080

Posted 4 months ago

Company Description

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. Our industry-leading drug discovery platform, which includes comprehensive proprietary libraries of the extracellular proteome and differentiated screening capabilities, has led to a pipeline comprising five development programs in clinical trials across multiple indications in 2019. We also have several undisclosed research programs that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process using our proprietary screens to discover new immuno-oncology targets.

Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. Discover more about FivePrime at

Job Description

We are seeking a highly motivated individual to join the Five Prime Therapeutics Inc. Biometrics team. This position will be responsible for managing study related statistical programming activities as well as developing, maintaining, and modifying SAS programs to generate and validate study and ad-hoc specific listings, summary tables and figures for clinical analyses. This position will report to the Senior Director of Statistical Programming.

Key Responsibilities:

  • Write or review SDTM and ADaM specifications prepared in-house or by CROs.

  • Develop, maintain, and modify SAS programs for publication, Investigator Brochure (IB), Development Safety Update Report (DSUR), and ad-hoc analyses.

  • Validate SDTM, ADaM, and tables/listings/graphs generated in-house or by CROs.

  • Review CRFs, edit check specification, data transfer plan, and statistical analysis plan.

  • Collaborate and coordinate the development of study plan and timeline with various internal departments and CROs.

  • Manage and monitor CROs by providing guidelines on study programming activities.

  • Ensure programming deliverable in-house or by CROs.

  • Exercise independent judgement in developing methods, techniques, and evaluation criteria for obtaining results.

  • Design and develop internal standard macro utilities.

  • Develop statistical programming standard operating procedures (SOPs) and work instructions.

  • Other duties as assigned.


  • BS in Statistics, Math or Scientific Discipline

  • 10+ years of industry experience with a minimum 5 years Pharmaceutical/Biotech programming experience

  • Solid Technical skills with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat

  • Experience as a senior statistical programmer level in a FDA regulated pharmaceutical or CRO environment

  • Experience with CDISC standard required

  • Knowledge of advanced statistical procedures in SAS including LIFETEST, PHREG, MIXED, and GLM.

  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment

  • Communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.

Additional Information

At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.

FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Statistical Programming

Seattle Genetics

Posted 4 months ago

VIEW JOBS 11/9/2019 12:00:00 AM 2020-02-07T00:00 Summary: Seattle Genetics is seeking a Manager, Statistical Programming to join our rapidly growing Biometrics team. You are the ideal candidate for this position if you can drive for results and communicate effectively in a highly collaborative environment, all while maintaining adaptability and high decision quality and creating the same environment for your direct reports. In this role, you will oversee statistical programming activities for Phase I-IV clinical studies. You will ensure that product and study-level deliverables are completed on time, in high quality, and in accordance with company, industry, and regulatory requirements. You will manage salaried, contract, and remote FSP programmers and be expected to manage not only work performance but also professional development and growth opportunities for your direct reports. Responsibilities: * Ensure accuracy, completeness, quality, and timely delivery of statistical programming deliverables at the study, filing, or small product level * Independently implement complex analysis algorithms for assigned projects or studies * Provide technical leadership to study team programmers including programming techniques. Decide on extent of implementation of departmental and product-level standards, tools, and processes in assigned studies with advice from the product lead programmer * Contribute to product-level specifications based on analysis need and ensure compliance with company and industry standards * Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; and case report forms * Clear and proactive communication with study and project teams to clarify requirements and specifications, update others on assignment status, and convey data irregularities * Initiate, lead, and participate in planned departmental and cross-functional initiatives that facilitate standards, infrastructure, and process enhancements * Manage resources efficiently across assigned projects to maximize synergies * Provide oversight, guidance, mentoring, feedback, and performance reviews to direct reports * Participate in interviews and, as a hiring manager, decide with candidates to hire. Train and mentor new and junior programmers * Assist programming management on resource allocation Qualifications: * 8+ years (BS) or 6+ (MS/PhD) of SAS programming experience in the Biotechnology, Pharmaceutical, Medical Device, and Health Care industries * 5+ years of experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings and figures for Phase I-IV clinical trials * 3+ years of experience in managing statistical programming projects, preferentially (but not necessarily) with direct line management responsibilities for internal salaried staff * 2+ years of experience in writing SAS macros * Demonstrated proactivity and strong attention to detail * Expert knowledge and understanding of SAS® programming concepts and skills. * Experience in oncology studies; experience with integrations and e-submissions a strong plus * Good understanding of and hands-on experience with CDISC SDTM and ADaM standards * BS, MS, or PhD 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 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. #LI-TC1 Seattle Genetics South San Francisco CA

Manager, Statistical Programming

Fiveprime Therapeutics, Inc.