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Manager, Statistical Programming

United States – RemoteBiometricsRegular

Job Description

Kite Pharma, a Gilead company, 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 hematological and solid malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.

We are in search of a Manager, Statistical Programming to join our team! Statistical Programming– Analysis Programming: Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.

Responsibilities (include but are not limited to):

  • Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting. Serves as project leader
  • Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries. Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis
  • Actively share experience and discuss possible process enhancements at programming meetings
  • Recommends potential trainings
  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
  • Responsible for all programming activities within a therapeutic project or equivalent
  • Implements strategic initiatives
  • Able to lead and manage multiple concurrent projects
  • Excellent verbal and written communication skills and interpersonal skills
  • Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions
  • Ability to resolve study related issues and conflicts within a therapeutic project
  • Can create buy-in and support and has the ability to negotiate timelines
  • Interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis
  • Participates in SMT (Study Management Team) meeting as a representative of Programming group

Basic Qualifications:

  • BS degree in Biostatistics/Computer Science or equivalent and 6 years’ experience in pharma/biotech -OR -
  • MS degree in Biostatistics/Computer Science or equivalent and 4 years’ experience in pharma/biotech –OR -
  • PhD degree in Biostatistics/Computer Sciences or equivalent 2 years of experience in pharma/biotech

Preferred Qualifications:

  • Degree in Biostatistics/Computer Science or equivalent
  • 6+ years of pharmaceutical/CRO experience
  • Prior experience in oncology, hematology, cell therapy strongly preferred.
  • Knowledge of long term follow up trial knowledge strongly preferred
  • Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.)
  • In-depth understanding of clinical programming and/or statistical programming processes and standards
  • In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
  • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros
  • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
  • Proven experience in leading programming activities
  • Excellent interpersonal, communication, problem solving, and analytical skills