Executive Director, Biostatistics
Harmony Biosciences
July 01, 2026
Remote friendly (Plymouth Meeting, PA)
United States
Clinical Research and Development
Responsibilities:
- Provide enterprise-level statistical leadership across the clinical development portfolio (early through late development, registration, lifecycle management) across therapeutic indications.
- Serve as senior biostatistics representative on cross-functional governance and portfolio review committees.
- Support study design, analysis, and quantitative decision-making; advise on statistical methodologies; perform modeling and simulations; leverage external experts.
- Lead statistical strategy for early-phase development (FIH, proof-of-concept, dose escalation/optimization, seamless Ph 1/II/III designs).
- Develop innovative adaptive methodologies (Bayesian approaches, response-adaptive randomization, platform trials, umbrella/basket studies, enrichment strategies, interim decision frameworks).
- Design and evaluate technical infrastructure to expedite trial conduct/evaluation; review key project/study documents for statistical presentation and compliance.
- Facilitate standards for variables/definitions/methods/data structures; provide statistical oversight for regulatory/medical expert meetings.
- Evaluate databases and statistical analysis programs; stay current on methodology and regulatory/industry trends.
- Participate in business development/due diligence as needed; build/mentor the biostatistics team; oversee resource planning, prioritization, and vendor oversight.
Qualifications:
- Ph.D. in Biostatistics or related quantitative discipline (required).
- 15+ years in pharma/biotech drug development with substantial leadership; experience across all stages, especially early development and adaptive trial designs (required).
- Proven leadership of statistical strategy across multiple programs and regulatory submissions.
- Deep experience with Bayesian methods, simulation, adaptive dose-finding, seamless designs, model-informed drug development.
- FDA interaction experience (required); EU regulatory/PMDA experience (plus).
- Ability to influence executive decision-making; high ethical/quality standards.
Benefits:
- Medical, Vision & Dental (first of month after start), generous PTO & company holidays, company-paid Disability & Life Insurance, 401(k), paid parental leave, ESPP, wellness programs, professional development.
- Provide enterprise-level statistical leadership across the clinical development portfolio (early through late development, registration, lifecycle management) across therapeutic indications.
- Serve as senior biostatistics representative on cross-functional governance and portfolio review committees.
- Support study design, analysis, and quantitative decision-making; advise on statistical methodologies; perform modeling and simulations; leverage external experts.
- Lead statistical strategy for early-phase development (FIH, proof-of-concept, dose escalation/optimization, seamless Ph 1/II/III designs).
- Develop innovative adaptive methodologies (Bayesian approaches, response-adaptive randomization, platform trials, umbrella/basket studies, enrichment strategies, interim decision frameworks).
- Design and evaluate technical infrastructure to expedite trial conduct/evaluation; review key project/study documents for statistical presentation and compliance.
- Facilitate standards for variables/definitions/methods/data structures; provide statistical oversight for regulatory/medical expert meetings.
- Evaluate databases and statistical analysis programs; stay current on methodology and regulatory/industry trends.
- Participate in business development/due diligence as needed; build/mentor the biostatistics team; oversee resource planning, prioritization, and vendor oversight.
Qualifications:
- Ph.D. in Biostatistics or related quantitative discipline (required).
- 15+ years in pharma/biotech drug development with substantial leadership; experience across all stages, especially early development and adaptive trial designs (required).
- Proven leadership of statistical strategy across multiple programs and regulatory submissions.
- Deep experience with Bayesian methods, simulation, adaptive dose-finding, seamless designs, model-informed drug development.
- FDA interaction experience (required); EU regulatory/PMDA experience (plus).
- Ability to influence executive decision-making; high ethical/quality standards.
Benefits:
- Medical, Vision & Dental (first of month after start), generous PTO & company holidays, company-paid Disability & Life Insurance, 401(k), paid parental leave, ESPP, wellness programs, professional development.