Senior Manager, Biostatistics Programming
Biostatistics | Santa Monica, CA | Full Time
Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.
We are seeking a highly motivated individual to join us as a Senior Manager, Biostatistics Programming. This person 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. 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 leadership for clinical studies, including but not limited to the resource estimate, development and validation of SDTM, AdaM and TFLs. Assumes responsibility of the overall timelines of planned and unplanned analyses of the studies.
- Provides 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.
- Recognizes and addresses issues which may affect the integrity of the data structure and reproducibility of analyses.
- Deep 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; providing programming resources and project management of clinical programming activities and deliverables.
- Provides programming input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
- Provides 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
- Demonstrated 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.
- Master degree or above 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
- Direct experience with a clinical trial submission
- Excellent verbal, written, and presentation skills
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 500 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.