Associate Director, Biostatistics Job Description

Associate Director, Biostatistics Job Description Template

Our company is looking for a Associate Director, Biostatistics to join our team.

Responsibilities:

  • Lead Biometrics Department Initiatives;
  • Interacts strategically with crossfunctional teams and other functional areas to ensure timely project deliverables;
  • Provide statistical expertise in the clinical development and lifecycle management activities for all assigned products;
  • Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations;
  • Actively participate in project teams as the Biostatistics lead;
  • Lead in development and adaptation of new statistical methodology in support of Theravance Biopharma drug development;
  • Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4;
  • Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments;
  • Reviews and negotiates baseline budget and timelines;
  • Leads the planning and analysis of integrated efficacy and safety data;
  • Lead assigned projects by applying project management skills, statistical and programming techniques to deliver quality and timely deliverables;
  • Ensures timely delivery of high-quality deliverables;
  • CRO / Vendor Oversight: Participates in drafting request for proposal for CRO selection.

Requirements:

  • Oncology /Hematology experience;
  • Demonstrated expertise in trial design and data analysis;
  • Excellent Project planning skills;
  • Expert knowledge of drug development and statistical methodologies;
  • Excellent programming skills in SAS. Familiar with CDISC;
  • Working knowledge of statistical software package such as nQuery, etc.