Position: Associate Director, Biostatistics
Key Responsibilities:
Strategic Contribution:
- Influence development strategy by recommending innovative designs and decision-making tools.
- Select and approve statistical methods for clinical trials, ensuring accurate analysis and interpretation.
- Oversee and approve statistical sections in reports and regulatory documents.
- Engage with regulatory authorities on statistical issues and guide teams on data interpretation.
- Manage statistical support across multiple projects.
Collaboration:
- Work with Medical Writers and Physicians to interpret study results.
- Contribute to publication plans and review scientific materials.
- Process Improvement:
- Lead or support initiatives to improve processes and maintain compliance with industry standards.
- Develop and standardize Biostatistics documentation formats and templates.
- Project Management:
- Plan, track, and optimize project activities and resource utilization.
- Additional Responsibilities:
- Perform other tasks as assigned by management.
Skills and Qualifications:
- Education: Master’s in Biostatistics or related field (Ph.D. preferred).
- Experience: 8+ years in the pharmaceutical industry, with Oncology and regulatory experience.
- Expertise: Advanced statistical methods, regulatory guidelines, and proficiency in statistical software (e.g., SAS).
- Decision-Making: Strong judgment, adaptability, and collaboration skills.
Additional Information:
- Travel: Some domestic and international travel required.
- Location: Boston, MA, with approximately two days per week onsite.
