Vice President (non- management), Biometrics

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 including  myeloid targets. As we advance our pipeline, we are looking for a highly motivated individual with experience in biostatistics to lead a biometrics team overseeing multiple teams (statistical programming, clinical data management) and clinical programs.

The VP biometrics is a member of the clinical team accountable for all biometrics deliverable from study concept through data analysis and regulatory submission. The desired candidate will be accountable for the overall strategy of the biometrics team including budget, staffing and oversight of CROs and alliance partners. The ability to function independently and interact with cross-functional groups to drive the business and teams forward is a key requirement for this position. This position reports to the Chief Medical Officer.

  • Leads the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines
  • Thorough knowledge of global regulatory guidance on biometrics
  • Accountability for the consistency and accuracy of data management and statistical programming deliverables, including derived data definition, analysis, files structure, analysis methodologies, and analysis results
  • Leads strategic decision making within Biometrics
  • Leads the development of standards within Biometrics
  • Understanding of regulatory guidelines that affect statistical deliverables including ICH, FDA and GCP regulations
  • Leads a biometrics team and provides guidance on key statistical analyses
  • Leadership skills and ability to interact and function with cross-functional teams in the organization
  • Provides comprehensive programing leadership and support to clinical development teams

Job Requirements

  • PhD in Statistics or Biostatistics with at least 14 years of pharma / biotech industry experience, or MS in Statistics or Biostatistics with at least 18 years of industry experience, and 5+ years of team leadership or management experience
  • Prior global regulatory filing experience such as NDA/BLA, prior MAA is an advantage
  • Expert knowledge in the principles and techniques of clinical study design, data analysis and interpretation, and data-driven decision making
  • Experience in managing technical professionals or CRO in regulated environment
  • Proficient in standard biotech/pharma industry statistical standards and use of applicable software in data structuring, SAS software and programming concepts and techniques
  • Experience in oncology, hematology strongly preferred
  • Broad experience in simulation guided drug development and evaluation of simulation guided trial designs using high performance computing
  • Highly skilled in leading change within an organization
  • Strong business acumen and critical thinking skills
  • Experience managing budget across multiple teams
  • Experience developing SOPs and business practice documents
  • Strong leadership, teamwork, and communication skills
  • Willing to travel if required
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