Sr. Manager, Statistical Programming

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 11, 2019
Ref
R0009110
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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 Director, Biostatistics Programming or delegate.

The Senior Manager, Biostatistics Programming will lead all programming aspects within multiple studies and indications within one or more products, 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, data documentation and archival, and interaction with regulatory authorities regarding filing structure and data content. The Senior Manager Biostatistics Programming may also 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):
  • Serve as project leader
  • Participate in cross-functional meetings as a representative of Statistical Programming group
  • Develop and manage programming services; providing programming resources and project management of clinical programming activities and deliverables
  • 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
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
  • Develop and implement standards related to derived data sets and submission data sets
  • 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.
  • Responsible for monitoring regulatory guidance and industry best practices
  • Provides programming input into the preparation of marketing applications to FDA, MEA or other worldwide regulatory agencies.
  • 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, document and support processes for achieving consistent results.


Requirements:
  • Experience in oncology clinical trials and data derivations
  • Expert knowledge and experience in solid tumor indications
  • Personnel management experience
  • Excellent verbal, written, and presentation skills
  • Experience in leading multiple studies
  • Direct experience with a regulatory submission including BLA, EMA and other regional filings
  • Hands-on experience in CDISC standards and datasets (SDTM, ADaM)
  • Advanced and broad knowledge of SAS, along with understanding of industry practices related statistical analyses, programming, and programming documentation
  • BS or MS in computer science, statistics, or mathematics

8+ years experience in statistical programming in a pharmaceutical company or contract research organization

*LI-RK1

IND-123

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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