Director, Statistical Programming

Job Description

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. Our therapeutic pipeline consists of immuno-oncology programs against novel drug targets we discovered computationally, including T cell immune checkpoints and additional early-stage immune-oncology programs focused largely on myeloid targets. As we advance our pipeline, we are looking for a highly motivated Director of Statistical Programming to lead multiple clinical programs.
The Director of Statistical Programming is a member of the clinical team who will be responsible for managing, leading, and overseeing statistical programming planning and operational activities to meet corporate objectives, timelines, and budgets. The Director is responsible for providing statistical programming support for multiple clinical projects multiple clinical studies through own effort and/or manage CROs, and provides guidance and direction to subordinates to achieve tasks in accordance with department and company goals. This person works closely with cross-functional teams including clinical development, biostatistics, safety/pharmacovigilance, clinical biomarker and data management colleagues on various clinical projects. The Director is responsible to liaise with data management and other functions to enhance the integrity of data. This position reports to the Chief Medical Officer.

  • Demonstrates extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry
  • Provides comprehensive programing leadership and support to clinical development teams
  • Oversees and manages internal or external programmers to provide programming for all aspects of statistical programming activities and validation, including SDTM and ADaM datasets, tables, listings, and figures (TFLs) for individual studies as well as ISS/ISE analyses
  • Reviews the data standardization plan, SDTM and ADaM data specifications, study data reviewer’s guide, and analysis data reviewer’s guide for submitted datasets per regulatory guidance
  • Manages or leads assignments and programming on multiple projects, ensures the outsourced projects are aligned to meet timelines, quality, and compliance expectations
  • Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines
  • Establishes and implements programming standards and complies with regulatory requirements among project team members and across studies
  • Performs the work of statistical programming services to achieve quality, timely, and cost-effective study deliverables, assistant with statistical quality assurance review
  • Mentors data management and statistical programming staff on data standards as relevant to their role

Job Requirements

  • MS in Biostatistics, Statistics, or related field required
  • 15 years experience of statistical programming within pharmaceutical clinical development
  • Experience in managing technical professionals or CRO in regulated environment
  • Regulatory knowledge and filing experience
  • Proficient in SAS software and programming concepts and techniques in the pharmaceutical industry
  • Experience of leading early and late-phase clinical studies including programming and validation of SDTM and ADaM datasets, and TFLs
  • Proficient in industry standards (CDSIC, SDTM and ADaM), medical terminology, and clinical trial methodologies
  • Possesses project management skills within the statistical programming function
  • Strong leadership, teamwork, and communication skills
  • Regulatory (FDA and EMA) submission experience
  • Willing to travel if required
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