Senior Manager, Statistical Programming
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
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We are seeking a highly motivated individual to join us as a Senior Manager, Statistical Programming . The Senior Manager, Statistical Programming will interact with other study Statistical Programmers, study Biostatistics, clinical data manager, regulatory affair and other functional areas within Clinical Development in supporting our efforts in this exciting new area of cancer immunotherapy.
The Senior Manager, Statistics 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. This role will also support programming activities and publications, data documentation and archival, and interaction with regulatory authorities regarding filing structure and data content and responses to requests. The Senior Manager, Statistical Programming may manage and oversee the work of outsourcing partners in addition to providing technical consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality.
Responsibilities (include but are not limited to):
- 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.
- Develop, document and support processes for achieving consistent results.
- 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.
- Provides programming input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
- Leads analyses in support of study planned or adhoc analysis or regulatory agency requests.
- Exhibits thorough knowledge of CDISC standards including SDTM and ADaM submission.
- Prepares and supports electronic submission of data and documentation (E.G. SAS datasets, Define.xml).
- 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 above in biostatistics, computer science, mathematics or equivalent.
- 8+ years of industry working experience in statistical programming in clinical trials or drug development industry.
- Advanced and broad knowledge of SAS, along with understanding of industry practices related statistical analyses, programming, and programming documentation.
- Hands-on experience in CDISC standards and datasets (SDTM, ADaM)
- Ability to learn new programming languages as required.
- Experiences in Oncology clinical trials and data derivations.
- Direct experience with a clinical trial submission.
- Experience in leading studies or analyses.
- Excellent verbal and written communication skills and interpersonal skills.
- Personnel management experience
Kite is a biopharmaceutical company 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.