Director, Statistics

Role Summary

The Director, MAHTA Statistics provides scientific and statistical leadership for drug development and life-cycle management across assigned therapeutic areas. The role partners with Medical Affairs, Market Access & Pricing, and other stakeholders to design, analyze, and report clinical and scientific research, generating evidence to support medical affairs and reimbursement strategies. The position leads the development of innovative study designs and analytical methodologies, including real-world evidence gathering and interpretation, and represents the function in cross-functional settings.

Responsibilities

• Provide scientific and statistical expertise for drug development and life-cycle management strategies; design, analyze, and report clinical and other scientific research programs; generate evidence to support medical affairs strategies; interact with health authorities, medical community, and KOLs regarding results.
• Demonstrate advanced statistical understanding; lead the introduction of new study designs/methodologies; explain statistical concepts to non-statisticians.
• Review technical or data-related issues in study design, conduct, or analysis; evaluate alternative analysis strategies; assess software needs and potential development of novel statistical methodologies.
• Maintain technical skills and knowledge of new statistical methods; present statistical research at meetings; uphold Statistics department standards, GxP compliance, and best practices.
• Collaborate with Medical Affairs, Clinical Statistics, Data Sciences, Statistical Programming, Market Access, and other stakeholders to assess databases, conduct feasibility assessments, and develop analysis plans for high-quality evidence generation and publications.
• Propose and direct evaluation of alternatives to traditional randomized trials using real-world data sources to fill evidence gaps.
• Represent MAHTA Statistics in cross-functional teams; ensure scientifically sound conclusions and timely, high-quality deliverables; provide in-depth statistical reviews for protocols, reports, and publications.
• Lead MAHTA Statistics in developing evidence-generation strategies and cross-functional collaboration; drive life-cycle management input and communications with product teams.
• Train and mentor staff in statistical methodology and operations; assist leaders in recruiting and professional development.

Qualifications

• MS (12+ years of experience) or PhD (8+ years of experience) in Statistics, Biostatistics, or related field.
• High level of technical competence with excellent oral and written communication skills.
• Experience in designing interventional and non-interventional studies; proficiency in descriptive/inferential statistics, modeling, and programming; expertise in confounding control and bias minimization in observational studies.
• Ability to identify data or analytical issues and provide solutions; experience supporting Medical Affairs and HTA activities is highly desirable.
• Ability to build strong cross-functional relationships and drive high performance.
• Motivated to drive innovation, open to learning and adapting new knowledge/technology; self-starter with a focus on turning possibilities into reality.
• Strong leadership skills with experience managing cross-cultural or overseas teams; in-depth understanding of pharmaceutical industry and regulated drug development/life-cycle management.