Senior Manager / Associate Director, Clinical & Statistical Programming
Location: South San Francisco, CA
Position type: Full-time, Regular
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development.
- Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
- FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
- FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma
Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas. 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 seeking a motivated and ambitious individual to join our Biostatistics and Programming 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 Director of Biostatistics and Programming.
- 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 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
Please upload your cover letter and resume