Executive Director, Biostatistics

Harmony Biosciences is recruiting for an Executive Director, Biostatistics in our Plymouth Meeting location. In this role you will provide enterprise-level statistical leadership across the clinical development portfolio with a strong emphasis on early development strategy, innovative adaptive clinical trial design, and quantitative decision-making. This individual will serve as a key strategic partner to senior leadership and cross-functional development teams, driving innovative and efficient approaches to clinical development, regulatory strategy, and portfolio advancement.

The role requires deep expertise in adaptive methodologies, extensive regulatory interaction experience, and demonstrated success leading complex development programs in a fast-paced biotechnology environment.

• 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
• Designs, develops, modifies and evaluates a technical infrastructure to expedite conduct and evaluation of clinical trials
• 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
• Develops / provides oversight on statistical matters for meetings with regulatory authorities, key opinion leaders and similar experts and bodies
• 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

• This position currently has supervisory responsibilities.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• 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…