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. 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 Statistical Programming to join our Biometrics team. 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.
- 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 Biostatistics and Programming Leadership Team for preparation of submission-readiness datasets (e.g. SDTMs, ADaMs) and TFLs 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 cross functions to maximize automation processes for data extraction, coding, reconciliation, and periodic data review listings/patient profiles to expedite clinical data review if applicable
- Ensure that all data components are conducted in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file
- Manage and work directly with CROs used for clinical/statistical programming; Provide guidance and monitor the progress of activities with CROs and other vendors
- Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines
- 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
- Bachelor’s or Master’s degree in Statistics or related fields; A Master’s degree is preferred
- 10+ years of statistical programming experience in the pharmaceutical industry, with oncology clinical trial experience strongly preferred
- 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 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.Please call or reply with any comments.