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 www.fiveprime.com.
We are looking for a talented Director of Biostatistics to join our Biometrics team. This individual will provide strategic technical leadership and biostatistics guidance on the design and conduct of clinical studies. In addition, this individual will provide support to project teams on all phases of clinical trials and drug development programs. This position reports to the Head of Biometrics
- Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
- Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines.
- Provide guidance and expertise to the clinical development team regarding biostatistics related subject matter
- Collaborate within Biometrics team and with cross-functional teams to plan clinical studies, analyze and interpret clinical study data.
- Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data
- Author and/ or review statistics section in the protocol, SAP and DMC charter. Lead regulatory responses and submissions to the FDA and other regulatory agencies.
- Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity
- Stay abreast of emerging technologies and concepts related to applied statistical methodology
- Recruit, develop, and supervise internal and external statistical resources to achieve department functional goals
- Engage and energize employees through communication of goals, priorities and other business critical information as well as focus on employee development and retention activities
- Develop and promote a work place culture that values diversity of thought and promote integrity to create an atmosphere that supports coaching and fosters accountability
- Ph.D. in Statistics or Biostatistics with 8+ years of direct experience in pharmaceutical or biotechnology industry
- Strong knowledge of statistical analysis methods and results/data presentation formats of oncology clinical data
- Good knowledge of drug development regulations pertinent to statistical analysis
- In-depth knowledge of regulatory regulations and ICH guidelines in drug development and approval with good experience in multiple FDA and EMA filings
- Proficient SAS programming skills, solid understanding of CDISC models and standards
- Excellent writing and interpersonal communication skills to build relationship cross-functionally and collaborate effectively
- Good organizational and problem-solving skills, as well as the ability to evaluate resource needs
- Ability to work within budget constraints, while utilizing resources efficiently and in a fiscally responsible manner.
- Ability to build a rapport and trust with others through leadership and dependability
- Ability to document deliverables following procedures with the utmost rigor and attention to detail
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.