Senior Manager, Biostatistics Programming
Biostatistics | Santa Monica, CA | Full Time
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
We are seeking a highly motivated individual to join us as a Senior Manager, Biostatistics Programming. You will work with the Biostatistics team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Associate Director, Biostatistics Programming.
The Senior Manager, Biostatistics Programming will lead all programming aspects within a clinical study or indication, including generation of standard and derived datasets, programming documentation, and tables, figures, and listings (TFLs) for all analyses. Additionally, the Senior Manager, Biostatistics Programming will support programming activities and publications for translational research, data documentation and archival, and interaction with regulatory authorities regarding filing structure and data content. The Senior Manager, Biostatistics Programming will manage and oversee the work of outsourcing partners as well as internal staff. Additionally, the Senior Manager, Biostatistics Programming will provide technical consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality.
Responsibilities (include but are not limited to):
- Provide programming expertise and input to planned and unplanned analyses, including the structure of standard and derived datasets, and the planned documentation of programming activities and TFLs.
- Recognize and addresses issues which may affect the integrity of the data structure and reproducibility of analyses.
- Thorough understanding of the theories and methodologies of conversion, tabulation, analysis, reporting, and integration of clinical data.
- Ability to apply knowledge of SAS ® programming application and other software languages and tools along with knowledge of industry-accepted standards, including CDISC SDTM and ADaM
- Develop and manage programming services; manage programming resources and projects for clinical programming activities and deliverables.
- Provide programming input into the preparation of marketing applications (NDA/BLA) to FDA, MAA, PMDA or other worldwide regulatory agencies.
- Provide strategic guidance and in-depth critical review for the development of Case Report Forms (CRFs) and database designs; ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
- Demonstrate proficiency in interpreting statistical analysis plans and developing analysis data set specifications, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Maintains programming documentation and ensures archival and reproducibility of all analyses.
- Develop and implement standards related to derived data sets and submission data sets
- Responsible for monitoring regulatory guidance and industry best practices
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
- BS or MS in computer science, statistics, or mathematics
- 10+ years experience in statistical programming in a pharmaceutical company or contract research organization
- Advanced and broad knowledge of SAS, along with understanding of industry practices related statistical analyses, programming, and programming documentation
- Ability to learn new programming languages as required
- Hands-on experience in CDISC standards and datasets (SDTM, ADaM)
- Experience in oncology clinical trials and data derivations
- Experience in multiple myeloma is desired
- Experience in PK/PD analyses is desired
- Direct experience with a clinical trial submission
- Excellent verbal, written, and presentation skills
Kite, A Gilead Company is an equal opportunity employer based in beautiful Santa Monica, CA. Kite, A Gilead Company offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com.
No phone calls please and no agencies or recruiters.