- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ:FPRX) discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime's comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company's R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
We are looking for a talented Associate Director/ Director of Biostatistics to join our Clinical Development function. 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 Chief Medical Officer. Responsibilities include and are not limited to the following:
- Collaborate within Biostatistics team and with cross-functional teams (clinical scientists, statistical programmers, clinical operations and clinical data management) to plan clinical studies, analyze and interpret clinical study data.
- Partner with CMO to develop department standards to ensure statistical integrity of project deliverables such as regulatory statistical and date requirements.
- Provide statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
- Contribute in strategy discussion in cross-functional project settings and act as indication lead statistician.
- Develop departmental metrics and tracking systems for data quality assurance.
- Develop standard reporting programs and standard CRF’s in collaboration with cross-functional groups.
- 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.
- Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines.
- Other projects when assigned.
- Ph.D. in Statistics or Biostatistics with 10+ years of direct experience in biotechnology industry
- Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS).
- Experience in design and development of statistical analysis plans, study protocols, clinical study reports
- Great knowledge of clinical operations, data management, and clinical study report preparation workflow
- In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data
- In-depth knowledge of regulatory regulations and guidelines
- Advanced knowledge of SAS, CDISC requirements for SDTM and ADaM.
- Clear and effective communication skills to present complex data to project teams including non-statisticians and easy for others to interpret and understand
- Excellent interpersonal communication skill to build relationship cross-functionally and collaborate effectively
- Strong leadership skill, problem solver and ability to influence business stakeholders on key decision-making process
- Proficiency in MS Word, Excel, PowerPoint, and Project.
All your information will be kept confidential according to EEO guidelines.