Biostatistics Leadership Position
Vor 6 Tagen
VectivBio, a global clinical-stage biotechnology company, is seeking a highly skilled Director, Biostatistics to join their team. As a key member of the Ironwood Pharmaceuticals organization, this role will play a critical part in ensuring statistical competencies are utilized to create value at the company.
Key Responsibilities- Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure optimal design and execution of clinical programs.
- Provide statistical consultations and strategic inputs to senior management and other staff within the company.
- Develop and adapt new statistical methodology in support of drug research and development.
- Lead in the development of study protocols, clinical study reports, and oversee generation of randomization schedules for complex randomization schemes.
- Review and approve primary and secondary manuscripts of clinical trial results.
- Develop statistical analysis plans for studies, perform complicated statistical analyses, and oversee generation of tables, listings, and figures for study reports and manuscripts.
- Review regulatory documents for accuracy and appropriateness of statistical interpretations and act as statistical liaison to FDA/regulatory agencies.
- PhD in Biostatistics/Statistics or related disciplines with 10 years of pharmaceutical experience, including direct supervisory and management experience.
- Strong knowledge of statistical methodology in design and analysis, including adaptive designs, Bayesian methods, and advanced statistical modeling.
- Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines.
- Strong knowledge of major statistical software programs such as SAS and/or R.
- Excellent analytical, problem-solving, and computer skills, as well as excellent verbal and written communication skills and interpersonal skills.
Ironwood Pharmaceuticals offers a dynamic and collaborative work environment, with opportunities for professional growth and development. The company is committed to advancing the treatment of gastrointestinal diseases and redefining the standard of care for GI patients.
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