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Manager, Statistical Programming

United States – RemoteBiometricsRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are in search of a Manager, Statistical Programming to join our team! 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 Kite’s regulatory, scientific and business objectives.

Responsibilities of the Manager, Statistical Programming 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 with Biometrics, Clinical Development, Clinical Data Science, and Regulatory Affairs groups on a frequent basis
  • Actively shares experience and discusses 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; leads and manages multiple concurrent projects
  • Resolves study related issues and conflicts within a therapeutic project
  • Creates buy-in and support and has the ability to negotiate timelines
  • 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 and 0+ years of experience in pharma/biotech

Preferred Qualifications:

  • Degree in Biostatistics/Computer Science or equivalent
  • 7+ years of pharmaceutical/CRO experience
  • Prior experience in oncology, hematology, cell therapy strongly preferred
  • Knowledge of long term follow up trials strongly preferred
  • Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.)
  • Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions
  • 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, verbal & written communication, problem solving, and analytical skills