Penfield Search Partners
Our client is a clinical-stage company specializing in the development of novel treatments for diseases in CNS therapeutic area, with several marketed products, strategic partnerships, and a diverse, healthy pipeline. They are seeking a flexible, dynamic Director of Biostatistics who is hands-on but also strategic. Reporting to the Executive Director of Biostatistics, this is a leadership role and an outward-facing position with a “seat at the table”; you will have access to senior leadership as well as FDA, and interact cross-functionally, both internally and externally. Big-picture thinking is important here, as the Director will have the opportunity to drive strategy at the compound level, interacting cross-functionally internally and externally with key opinion leaders and FDA. The Director who will be successful here thrives on a high-growth, fast-paced environment where they will have the opportunity to have their ideas heard.
The Director will:
- Serve as overall statistical lead and point of contact representing Biometrics in partnership with Medical Affairs, Health Economics and Outcomes Research (HEOR), and other departments to support the development and execution of real world evidence (RWE) strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings and dissemination/publications.
- Ensure scientific rigor and serves as the analytical methodology expert for RWE study designs and data analyses across various data types and applications.
- Provide strategic and tactical support for cross-functional RWE development for regulators, payers and clinicians.
- Serve as subject matter expert for RWE/HEOR research design, methodologies, data sources, analytic techniques, and reporting.
- Leverage administrative claims, electronic medical records, or other real-world data and recommend optimal study designs.
- Select and implement appropriate analytical methods including statistical models or machine learning models to align with overall business objectives.
- Develop high quality study protocols, statistical analysis plans, study reports, and other study documents.
- Identify innovation opportunities for the use of RWD.
- Establish effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWE.
- Collaborate with and manage vendors to ensure project timelines and goals are met.
Desired for the Role:
- MS in Statistics/Biostatistics and 10+ years of experience leading the design and conduct of observational research in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements
- PhD in Statistics, Biostatistics and 7+ years
- Experience in the development of drug development strategies in the pharmaceutical industry setting including innovative study designs and advanced statistical methods
- Ability to drive strategic direction into tactical plans
- Strong mentoring skills and leadership abilities
- Experience with different applications of RWE, including support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements
- Knowledge of global regulatory and HTA requirements for RWE
- Demonstrated ability in the evaluation and development of RWE from conceptualization through application
- Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development
- Extensive working experience with stakeholders such as medical affairs and health economics
- Hands-on experience with prospective and retrospective observational studies
- Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries
- High level of competency using standard statistical software such as SAS or R
- Ability to effectively interpret and communicate research results to internal and external audiences