Biostatistics Leader for Clinical Development
vor 3 Wochen
Overview
VectivBio, a global clinical-stage biotechnology company, and Ironwood Pharmaceuticals, a leading gastrointestinal healthcare company, are joining forces to advance the treatment of severe rare conditions. As a Director, Biostatistics, you will play a crucial role in ensuring statistical competencies drive value creation at this combined entity.
Salary Range: $180,000 - $250,000 per annum, based on location and experience.
Job Description:
The successful candidate will be responsible for strategic contributions to clinical development plans, regulatory strategies, and life cycle planning. You will provide statistical consultations and strategic inputs to senior management and other staff within the organization. Key responsibilities include developing statistical analysis plans, performing complicated statistical analyses, and overseeing the generation of tables, listings, and figures for study reports and manuscripts.
Required Skills and Qualifications:
- 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.
- Familiarity with FDA/ICH guidelines, CDISC standards, and 21 CFR Part 11.
- Experience with major statistical software programs such as SAS and/or R.
- Excellent analytical, problem-solving, and computer skills.
- Fluent in spoken and written English.
Benefits:
- Premium health insurance
- Dental and vision insurance
- Retirement plan (401(k)) with company match
- Generous paid time off policy
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