Principal Biostatistician

Actalent - Waltham, MA

Full-time - Principal

Hybrid - Waltham, MA

10,001+ employees

Administrative and Support Services

About the position

The Principal Biostatistician serves 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, ensuring timely delivery of statistical outputs for clinical trials and health authority submissions. The Principal Biostatistician will report to a disease area team leader within the Biostatistics and Statistical Modelling organization and will adhere to company guidelines and regulatory requirements.

Responsibilities

• Serve as the statistical leader in the cross-functional development team for one compound/indication.
• Provide statistical expertise to the development strategy, decision making, and interpretation of 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 HA 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 with a minimum of 6 years experience.
• 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).
• Able to collaborate with program partners and stakeholders.
• Clearly explain complex statistical concepts in written and spoken English.
• Team-player with a focused attitude.
• Able to work autonomously as part of a cross-disciplinary team in a dynamic environment.

Benefits

• Competitive salary
• Extensive benefits
• Opportunities for growth in a creative and innovative team environment