Associate Director, Biostatistics
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
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 will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology.
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.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at 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 Head of Biometrics.
- 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 the Head of Biometrics to develop department standards to ensure statistical integrity of project deliverables such as regulatory statistical and data 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 especially Oncology trials, 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 for regulatory submissions
- In-depth knowledge of regulatory guidelines, Integrated summaries of Efficacy and Safety
- 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.
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.