Executive Director, Biostatistics
Harmony Biosciences
August 14, 2026
On-site
Plymouth Meeting, PA
Clinical Research and Development
Responsibilities:
- Provide enterprise-level statistical leadership across the clinical development portfolio (early through late development, registration, and lifecycle management) across multiple therapeutic indications.
- Serve as senior biostatistics representative on cross-functional governance and portfolio review committees.
- Support clinical teams with study design, analysis, and 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 expertise in adaptive and innovative trial designs (Bayesian methods, response-adaptive randomization, platform trials, umbrella/basket studies, enrichment strategies, interim decision frameworks).
- Design and evaluate technical infrastructure to expedite clinical trial conduct and evaluation.
- Review key project/study documents for statistical presentation and compliance; facilitate standards for variables, definitions, methods, data structures, and data presentation.
- Provide statistical input/oversight for meetings with regulatory authorities and external experts.
- Evaluate databases and statistical analysis programs for optimal technical solutions.
- Stay current on statistics, regulatory guidance, and industry trends; signal relevant developments.
- As needed, support business development and due diligence with data review.
- Build, mentor, and develop biostatistics team capabilities; oversee resource planning/prioritization and vendor oversight; align statistical strategy with corporate objectives.
Qualifications:
- Ph.D. in Biostatistics or related quantitative discipline (required).
- 15+ years in pharma/biotech drug development with leadership across all stages, especially early development and adaptive trial designs (required).
- Demonstrated success leading statistical strategy across multiple therapeutic programs and regulatory submissions.
- Extensive experience with Bayesian methods, simulation techniques, adaptive dose-finding, seamless designs, and model-informed drug development.
- Experience with health authority interactions (e.g., FDA); experience with European regulators and PMDA (plus).
- Ability to influence executive leadership and drive enterprise-level decision-making; strong ethical/quality standards.
- Ability to work independently with minimal guidance; recognized scientific leadership; identify improvement opportunities; lead/mentor small teams.
Benefits:
- Medical, Vision and Dental (first of month following start date)
- Generous paid time off and company-designated holidays; paid parental leave
- Company-paid disability benefits and life insurance
- 401(k) Retirement Savings Plan
- Employee Stock Purchase Plan (ESPP)
- Company-sponsored wellness programs
- Professional development and continuous learning opportunities
Supervisory Responsibilities: This position has supervisory responsibilities (hiring, training, performance management, directing work, etc.).
- Provide enterprise-level statistical leadership across the clinical development portfolio (early through late development, registration, and lifecycle management) across multiple therapeutic indications.
- Serve as senior biostatistics representative on cross-functional governance and portfolio review committees.
- Support clinical teams with study design, analysis, and 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 expertise in adaptive and innovative trial designs (Bayesian methods, response-adaptive randomization, platform trials, umbrella/basket studies, enrichment strategies, interim decision frameworks).
- Design and evaluate technical infrastructure to expedite clinical trial conduct and evaluation.
- Review key project/study documents for statistical presentation and compliance; facilitate standards for variables, definitions, methods, data structures, and data presentation.
- Provide statistical input/oversight for meetings with regulatory authorities and external experts.
- Evaluate databases and statistical analysis programs for optimal technical solutions.
- Stay current on statistics, regulatory guidance, and industry trends; signal relevant developments.
- As needed, support business development and due diligence with data review.
- Build, mentor, and develop biostatistics team capabilities; oversee resource planning/prioritization and vendor oversight; align statistical strategy with corporate objectives.
Qualifications:
- Ph.D. in Biostatistics or related quantitative discipline (required).
- 15+ years in pharma/biotech drug development with leadership across all stages, especially early development and adaptive trial designs (required).
- Demonstrated success leading statistical strategy across multiple therapeutic programs and regulatory submissions.
- Extensive experience with Bayesian methods, simulation techniques, adaptive dose-finding, seamless designs, and model-informed drug development.
- Experience with health authority interactions (e.g., FDA); experience with European regulators and PMDA (plus).
- Ability to influence executive leadership and drive enterprise-level decision-making; strong ethical/quality standards.
- Ability to work independently with minimal guidance; recognized scientific leadership; identify improvement opportunities; lead/mentor small teams.
Benefits:
- Medical, Vision and Dental (first of month following start date)
- Generous paid time off and company-designated holidays; paid parental leave
- Company-paid disability benefits and life insurance
- 401(k) Retirement Savings Plan
- Employee Stock Purchase Plan (ESPP)
- Company-sponsored wellness programs
- Professional development and continuous learning opportunities
Supervisory Responsibilities: This position has supervisory responsibilities (hiring, training, performance management, directing work, etc.).