The Director, Biostatistics is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct, and analysis of sponsored studies. Having both technical and vendor management responsibilities, this role is responsible for the appropriate use of statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics and clinical data management. Performance in this role relies on significant experience in clinical study design and programming as well as sound judgment to plan and accomplish goals. In this role, the Director, Biostatistics will serve as the Biostatistics project lead for one or more indications for compounds under study, including input to the drug development and regulatory strategy.
- Provides statistical support as Biostatistics project lead for one or more compounds, including input into design and analysis of clinical trials, vendor oversight, and submission activities. It is anticipated that this person will provide support for one or more indications for compounds under study.
- Ensures the relevance and adequacy of statistical methods employed in sponsored clinical development activities
- Ensures conformance to relevant regulatory guidelines and Good Clinical Practice, as applicable to Biometrics
- Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design
- Participates in the selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities, including oversight of statistical programming
- Utilizes statistical software (SAS, NQuery, JMP and/or Prism) for internal ad hoc requests for data analysis, samples sizes, graphics etc.
- Participation in clinical development/product management teams in support of organizational objectives
- Participation in meetings with regulatory agencies such as the FDA
- Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement
- Monitoring and evaluation of relevant performance metrics
- Author/ reviewer of relevant sections of critical documents required to support the development of the companies products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts, and manuscripts
- Responsible for accuracy of all data included in public corporate communications of the companies clinical trial results, including press releases, slide presentations, scientific meeting abstracts, and published manuscripts
- Ability to communicate technical concepts to cross-functional partners at the company, to technical and regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor
- All other duties as assigned
- MS or PhD in Biostatistics (or related field) with at least 5 years experience in the pharmaceutical industry, with relevant experience in the design, analysis and interpretation of clinical trials, and with sufficient SAS programming experience to support these activities. Prefer at least 10 years experience.
- Proven expertise with the disciplines, practices, and procedures that pertain to biostatistics, programming, and understanding of clinical data management processes
- Demonstrated knowledge of the clinical development process and of relevant regulatory guidelines and requirements
- Leadership skills both functional and cross functional
- Takes a hands-on approach (e.g. will do analyses him/herself when necessary)
- Excellent written and verbal communication skills
- Proven team player with ability to work well in a collegial environment: willing to challenge the status quo
- Experience in design and analysis of Phase II/III trials.
- Experience providing analyses to data monitoring committees and/or study steering committees
- Experience with regulatory submissions and interactions with regulatory agencies
- Flexible scheduling and ability to travel internationally
- Small company attitude, embraces change within a high-risk environment