The Associate Director/Director of Biostatistics will serve as a subject matter expert, overseeing clinical study deliverables and providing strategic and operational support for clinical development programs. This role involves collaborating on clinical trial designs, statistical methodologies, and the execution of innovative strategies. The position includes assisting in the development of departmental policies and operational guidelines while contributing expertise to clinical development and statistical design.
The ideal candidate will have a proven track record in leading teams, managing functional growth, and implementing effective strategies. Strong communication skills are essential to collaborate with cross-functional teams and senior leadership, providing direction and influencing program outcomes.
Key Responsibilities
- Provide statistical expertise to support global clinical development programs.
- Lead analytical efforts to develop efficient clinical development strategies and guide decision-making.
- Design and implement innovative statistical methodologies, including Bayesian methods, adaptive designs, and modeling techniques.
- Stay current with emerging technologies and applied statistical methodologies.
- Oversee statistical design, execution, and analysis of clinical trials across all phases.
- Review study protocols and case report forms for optimal trial design.
- Develop and author statistical analysis plans for clinical trials.
- Collaborate with clinical teams, including clinical operations, translational medicine, and pharmacovigilance, to analyze and interpret study results.
- Contribute to the creation of interim reports, final study reports, and publications.
- Direct the development of integrated safety and efficacy summaries for regulatory submissions.
- Provide statistical guidance to pre-clinical and research teams for experimental design and modeling activities.
- Evaluate and manage contract research organizations (CROs) and other vendors to ensure timely, high-quality deliverables.
- Establish and enforce department standards to maintain the statistical integrity of project deliverables.
Qualifications
- Advanced degree in statistics, biostatistics, mathematics, computer science, or a related field.
- Minimum of 8 years (for Associate Director) or 10 years (for Director) of experience leading clinical biostatistics efforts in the biotech or pharmaceutical industry.
- Expertise in oncology clinical development across all phases.
- Experience managing technical professionals in a regulated environment is highly desirable.
- Proven ability to mentor teams and manage multiple clinical programs simultaneously.
- Strong knowledge of the drug development process, clinical trial methodologies, and regulatory requirements.
- Experience with innovative data visualization tools like Spotfire, Tableau, or R-Shiny.
- Familiarity with statistical software such as SAS, R, and EAST, along with dynamic reporting techniques.
- Demonstrated ability to operate effectively in dynamic environments, fostering successful collaborations across diverse teams.
- Proficiency in managing vendor relationships, including contracting, evaluation, and deliverable quality assurance.
- Strong organizational and multitasking skills, with the ability to prioritize effectively.
- Excellent verbal and written communication skills, with a proactive approach to collaboration.
