Executive Director, Biostatistics

Responsibilities

• Provide strategic leadership across multiple development programs across different therapeutic indications, from early through late development, registration, and lifecycle management
• Serves as senior biostatistics representative on cross-functional governance and portfolio review committees
• Actively supports clinical development teams on statistical elements of study design, analysis and decision-making issues. Provides expert opinion, advises on available statistical methodologies, performs modeling and simulations, and leverages external experts to provide help to clinical development issues
• Leads statistical strategy for early-phase clinical development including First-in-Human (FIH), proof-of concept, dose escalation, dose optimization, and seamless Ph 1/II/III designs
• Provides expertise in innovative and adaptive clinical trial methodologies including Bayesian approaches, response-adaptive randomization, platform trials, umbrella/basket studies, enrichment strategies, and interim decision frameworks
• Reviews key project and study documents to ensure optimal statistical presentation and compliance
• Facilitates and oversees creation of standards with respect to key variables, definitions, statistical methods, data structures and presentation of data
• Provides expertise in innovative and adaptive clinical trial methodologies including Bayesian approaches, response-adaptive randomization, platform trials, umbrella/basket studies, enrichment strategies, and interim decision frameworks
• Evaluates databases and statistical analysis programs to determine optimal technical solutions
• Stays at the cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in drug development, and signals relevant developments in a timely manner for the company
• As needed, participates in reviewing business development opportunities and due diligence activities and reviews data and provides input to the broader business development team
• Builds, mentors, and develops high-performing biostatistics team dn organizational capabilities
• Oversees resource planning, prioritization, and vendor oversight across multiple concurrent programs
• Provides enterprise-level leadership across programs, aligns statistical strategy with corporate objectives and portfolio priorities; influences executive decision-making through scientific expertise
• Leads effectively, gains alignment across functions and stakeholders, builds trust and credibility both internally and externally

Qualifications

• Ph.D. in Biostatistics or related quantitative discipline required
• 15+ years of experience in pharmaceutical/biotech drug development with substantial leadership experience required including experience with all stages of drug development, particularly early clinical development and innovative, adaptive trial designs
• Demonstrated success leading statistical strategy across multiple therapeutic programs and regulatory submissions
• Extensive experience with Bayesian methodologies, simulation techniques, adaptive dose-finding, seamless trial designs, and model-informed drug development
• Experience in interactions with health authorities such as FDA; Experience in interactions with European regulatory bodies and PMDA is a plus
• Demonstrated ability to influence executive leadership and drive enterprise-level decision making
• Understanding of the various functions and expert groups contributing to Drug Development
• High ethical & quality standards and lives them through actions and communication
• Demonstrated ability to function independently with minimal guidance while simultaneously covering multi-varied project responsibilities
• Recognized scientific leadership through publications, conference presentations, professional society involvement etc.
• Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems
• Demonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as required