What are the responsibilities and job description for the Assoc. Director, Biostatistics position at IntePros?
Associate Director, Biostatistics
We are looking for an experienced Associate Director, Biostatistics to lead statistical strategy, analysis, and oversight for clinical development programs. This role supports high-profile projects while managing a team of biostatisticians to ensure the highest quality and compliance with regulatory standards.
Key Responsibilities
We are looking for an experienced Associate Director, Biostatistics to lead statistical strategy, analysis, and oversight for clinical development programs. This role supports high-profile projects while managing a team of biostatisticians to ensure the highest quality and compliance with regulatory standards.
Key Responsibilities
- Strategic Leadership:
- Collaborate with cross-functional teams to develop statistical strategies for clinical trials (Phases I-IV).
- Provide input on protocol design, sample size calculations, and endpoint selection.
- Contribute to regulatory submissions and respond to agency queries.
- Team Management & Mentorship:
- Lead and mentor a team of biostatisticians, fostering growth and professional development.
- Assign resources, delegate tasks, and monitor project progress.
- Conduct performance reviews, provide constructive feedback, and develop training plans.
- Operational Oversight:
- Oversee the development of statistical analysis plans (SAPs) and ensure timely, high-quality deliverables.
- Review and validate datasets, TLFs (tables, listings, figures), and statistical outputs.
- Collaborate with Data Management and Programming teams to ensure data integrity.
- Process Improvement & Innovation:
- Drive the development of SOPs and best practices for statistical methodologies.
- Stay updated on industry trends and innovative biostatistical approaches.
- Lead internal training and knowledge-sharing initiatives.
- Client Engagement & Business Development:
- Support proposal development, bid defenses, and client presentations.
- Build relationships with sponsors, providing statistical expertise and guidance.
- Master’s or Ph.D. in Biostatistics, Statistics, or a related field.
- 12 years of experience in biostatistics for clinical trials, with at least 5 years in a leadership role.
- Expertise in statistical programming languages (e.g., SAS, R).
- In-depth knowledge of FDA, EMA, and ICH guidelines.
- Strong leadership, communication, and problem-solving skills.
- Proven ability to manage multiple projects and teams simultaneously.
