Senior Director, Statistical Programming
- 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 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 motivated and ambitious individual to join our Biometrics group. This position will be responsible for programming support (Clinical and Statistical Programming) and Development computing and analytical environment in support of Clinical Development projects and pipelines. This position reports to the Head of Biometrics.
Ensure successful leadership for a global statistical programming function
Lead a team of statistical programmers / consultants
Maintain consistent standardization of data across the global group
Chair the data standards teams for each assigned therapy area
Provide consultative advice on complex statistical programming issues, submissions and other matters relating to data standards
Provide strategic and technical programming expertise in relation to global regulatory submissions
Identify and establish secured computing/analytical environment, programming standards and practices to ensure alignment between programming strategic direction and company’s R&D strategies.
Oversee the development and implementation of programming SOPs and work instructions, including programming validation and documentation.
Provide programming leadership and guidance as a member of the Biometrics Leadership Team for preparation of submission-readiness datasets (e.g. SDTMs, ADaMs) and TLGs to FDA, EMA, or other worldwide regulatory agencies.
Develop and maintain programming infrastructure standards to support CSR, ad hoc analysis, publications, DSUR, etc.
Lead and work collaboratively with business stakeholders such as Clinical Science, Clinical Operation, Data Management, Biostatistics, Drug Safety, regulatory, and Medical Writing to maximize automation processes for data extraction, coding, reconciliation, and periodic data review listings/patient profiles to expedite clinical data review if applicable.
Ensure the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit.
Develop programming function budgets and requirements.
Manage and work directly with CROs used for clinical/statistical programming; Provide guidance and monitor the progress of activities with CROs and other vendors.
Bachelor or Master’s Degree in Statistics or related fields; A Master’s degree is preferred
10+ years of clinical/statistical programming experience in the Pharmaceutical/Biotech industry or CRO
Extensive experience managing CROs or FSPs to scale up or down as the workload permits
Good knowledge of drug development regulations pertinent to statistical analysis
Solid experience with global clinical trial practices, procedures, and methodologies
Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Excellent written and interpersonal communication skills
Proven ability to influence and collaborate with business stakeholders effectively and in a positive manner
Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
Think strategically and add value by bringing unique insight to team
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.