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.