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Director – Medical Affairs Biostatistics
| Company | Insmed |
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| Location | United States |
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| Salary | $179000 – $250800 |
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| Type | Full-Time |
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| Degrees | PhD |
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| Experience Level | Expert or higher |
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Requirements
- Ph.D. in Statistics or Biostatistics with over 8 years of pharmaceutical experience.
- Strong knowledge of pharmaceutical environment and broad experience with multi-phase development.
- Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applicable to clinical research.
- Strong project management, interpersonal and communication skills.
- Ability to influence and contribute to the advancement of innovative statistical methodologies.
- Hands-on experience in designing and analyzing clinical trial data, with proficiency in SDTM and ADaM datasets and statistical software such as SAS and R.
- Prior experience in HTA, RWE and post-marketing studies is higher desired.
Responsibilities
- Lead the Medical Affairs statistical activities for one or several compounds.
- Represent the Biostatistics team within cross-functional teams, being accountable for statistical aspects of post-marketing studies, Real-World Evidence (RWE) studies, Heath Technology Assessment (HTA) submissions and publications.
- Oversee timelines and the quality of statistical analyses conducted by both CROs or internal teams.
- Independently undertake advanced statistical methods to support medical decision-making and evidence generation across Medical Affairs activities.
- Promote collaboration across Biometrics and other cross-functional teams, ensuring effective communication and the integration of statistical expertise into key business decisions.
- Contribute to department and transversal initiatives, supporting organizational growth.
- Provide technical guidance and mentorship to junior statisticians.
Preferred Qualifications
- Prior experience in HTA, RWE and post-marketing studies is higher desired.
