Manager, Statistical Programming
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. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that positions us to discover novel pathways and targets in immuno-oncology and will continue to generate important development programs. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
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.
The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com
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.
- 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.
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.