Director of Biostatistics
Boston, Massachusetts
Pharmaceutical Manufacturing
Full time/ direct hire
$190,000 - $250,000
Job Summary:
The Director of Biostatistics will lead and oversee all statistical activities within the pharmaceutical manufacturing division, including clinical trials, product development, and regulatory submissions. This role requires a visionary leader who can design innovative statistical strategies, ensure the integrity and accuracy of data, and collaborate across multidisciplinary teams to advance drug development programs. The ideal candidate will have extensive experience in clinical biostatistics, regulatory compliance, and a deep understanding of drug development and manufacturing processes.
Key Responsibilities:
Leadership & Strategy:
- Lead the biostatistics team in designing and implementing statistical methodologies for clinical trials, product development, and manufacturing.
- Drive statistical innovation, ensuring the application of cutting-edge biostatistical approaches.
- Collaborate with cross-functional teams (clinical operations, R&D, regulatory affairs, quality assurance) to align statistical strategies with business goals.
- Provide high-level biostatistical input to support clinical study design, protocol development, and regulatory submissions.
- Act as a key advisor to senior leadership on statistical issues and implications for business decisions.
Clinical Development:
- Oversee the statistical design and analysis of clinical trials, ensuring compliance with regulatory guidelines (FDA, EMA, etc.).
- Ensure high-quality, timely analysis and interpretation of data to inform critical decisions in drug development.
- Participate in protocol reviews, statistical analysis plans (SAPs), data monitoring, and interim analyses.
- Review and provide statistical guidance on clinical study reports, abstracts, publications, and presentations.
Regulatory & Compliance:
- Ensure that all statistical methodologies meet global regulatory standards.
- Provide leadership in regulatory submissions, including preparation of statistical sections for INDs, NDAs, and other submission documents.
- Serve as a key point of contact for regulatory agencies, addressing statistical queries and concerns during audits or regulatory reviews.
- Maintain knowledge of current and evolving regulatory requirements and statistical methodologies.
Collaboration & Communication:
- Work closely with external partners, including contract research organizations (CROs), academic institutions, and industry consortia.
- Communicate complex statistical concepts and results to non-statistical audiences, ensuring clear understanding by internal stakeholders.
- Collaborate on the development of manuscripts and presentations for scientific conferences and publications.
Required Qualifications:
- Ph.D. in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 10+ years of experience in biostatistics within the pharmaceutical, biotechnology, or healthcare industries.
- Proven track record of leadership in biostatistics, with experience in directing teams in clinical trial design, statistical analysis, and regulatory submissions.
- Strong knowledge of regulatory requirements (FDA, EMA) and ICH guidelines.
- Experience in all phases of clinical trials (Phase I-IV) and with different therapeutic areas.
- Proficiency in statistical software (e.g., SAS, R) and clinical trial data management systems.
Preferred Qualifications:
- Experience working with drug manufacturing processes and quality control.
- Experience with adaptive trial designs, Bayesian methods, or real-world data analysis.
- Familiarity with data science, machine learning, or artificial intelligence applications in biostatistics.
- Experience in authoring peer-reviewed publications and presenting at scientific meetings.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Professional development and continuing education opportunities.
- Relocation assistance (if applicable).