Director, Biostatistics (LN20-252)
The Director, Biostatistics will lead Biostatistics support for one or multiple therapeutic areas to ensure that Catalyst Biosciences Research and Development projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions. Accountable for the statistical strategy and design in all assigned projects for full compound development and product life cycle. Provides input to clinical development plans, protocols, clinical study reports, regulatory submissions, abstracts, and manuscripts to align statistical elements with the overall product strategy.
Represents Biostatistics function in meetings with cross-functional project teams and regulatory agencies. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training; leading in the development and adaptation of the latest statistical methodologies and regulatory guidance in the global environment; hiring, mentoring and managing employees to maintain a competent and qualified staff; selecting and hiring and overseeing qualified and cost-effective CRO's to supplement internal resources; and monitoring the performance of CRO's to ensure high quality products and services.
ABOUT CATALYST BIOSCIENCES
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet medical needs in patients with rare bleeding and complement related disorders. Catalyst currently has compounds in discovery and development phases that span the value chain from the early discovery stage to late stage clinical trials with the intent of commercialization.
- Plans, organizes, and directs Biostatistics activities to support clinical programs. This includes optimal design, proper analysis and clearly presentation of data both in written and oral form to support new product development, regulatory submissions, and the maintenance and growth of existing products
- Participates in establishing and maintaining policies, and standards operating procedures for Biostatistics
- Leads in development and adaptation of new statistical methodology in support of clinical research and development, keeping current with regulatory guidance and requirements
- Provides statistical consultations and strategic inputs for drug development in cross-functional teams
- Oversee CROs biostatistics function and direct reports, SAP creation and amendments, TFL development and finalization, CSR development, review and finalization
**Title/Level will commensurate with education and experience.
- Advanced degree in Statistics/Biostatistics (PHD preferred)
- 8-10 years or more of direct hands-on pharmaceutical experience
- Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development
- BLA/NDA experience as well as past interactions with FDA
- Working knowledge of major statistical software programs
- Experience in rare disease a plus
- Programming oversight/experience a plus
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to email@example.com, referencing requisition number (LN20-252) in the subject line.