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Principal Biostatistician
Actalent - Boston, MA
posted about 2 months ago
About the position
The Principal Biostatistician will serve as the statistical leader within a cross-functional development team for a specific compound or indication. This role involves providing statistical expertise to inform development strategies, decision-making, and data interpretation throughout the clinical development program. The position emphasizes excellence and innovation in quantitative methods, requiring collaboration with program partners to ensure timely statistical deliverables for clinical trials and health authority submissions.
Responsibilities
- Serve as the statistical leader in the cross-functional development team for one compound/indication.
- Provide statistical expertise to the development strategy and decision-making processes.
- Interpret data generated through the clinical development program.
- Collaborate closely with program partners and stakeholders to deliver on-time statistical deliverables for all clinical trials and/or health authority submissions.
- Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements.
Requirements
- Master or doctorate (Ph.D.) degree in Statistics or related field.
- Minimum of 6 years experience in biostatistics or related field.
- Expertise in drug development in a regulatory environment.
- Advanced knowledge of biostatistics and its application to clinical trials.
- Experience in clinical trial design and scenario-planning.
- Extensive experience in the Pharma or Biotech environment.
- Ability to plan, supervise, implement, and monitor statistical processes for multiple clinical trials.
- Expertise in Bayesian statistics.
- Proficient in statistical software (SAS and/or R).
Nice-to-haves
- Ability to collaborate with program partners and stakeholders.
- Clear communication of complex statistical concepts in written and spoken English.
- Team-player with a focused attitude.
- Ability to work autonomously as part of a cross-disciplinary team in a dynamic environment.
Benefits
- Competitive salary with extensive benefits.
- Opportunity for growth in a creative and innovative team.
