Executive Director, Biostatistics - Medical Affairs

About the role

The Executive Director of Biostatistics for Medical Affairs will lead the Biostatistics function for Medical Affairs studies across all therapeutic areas. This role will provide statistical oversight, strategic input, and team leadership.

Responsibilities

• Provides statistical oversight of all biostatisticians supporting Medical Affairs and all biostatistics-related work conducted by internal biostatisticians and external consultants.
• Provides strategic statistical input and expertise for Medical Affairs studies, observational studies, and broader evidence-generation activities across the portfolio, in partnership with relevant functions including RWE and HEOR.
• Oversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resources.
• Buils, develops, and leads the Medical Affairs Biostatistics team, including team structure, staffing plans, capability development, and operating model.
• Negotiates project timelines across programs with competing priorities given constraints.
• Manages and coordinates limited resources to produce quality deliverables within timelines.
• Develops and ensures adherence to SOPs, BEDs, and all departmental standards and processes regarding the conduct of Medical Affairs studies, statistical methodology, data analysis, and interpretation.
• Champions the development and training of decision-enabled statistical tools.
• Explores opportunities for more efficient and innovative statistical approaches.
• Ensures the scientific integrity of statistical methods applied to Medical Affairs studies and maintains rigorous statistical standards across the portfolio.
• Encourages and empowers biostatisticians to exercise good judgment, embrace a data-driven approach, and follow best practices and principles to become accountable decision-makers.
• Participates in relevant cross-functional leadership meetings, and represents the Biostatistics function.
• Provides clarity on expectations for biostatisticians supporting Medical Affairs, including delegation, decision-making, and communication framework.
• Provides constant constructive feedback accordingly.
• Develops talent action plans to ensure retention of top talent.
• Ants up to upcoming challenges, identifies potential capability gaps, and utilizes internal and external resources to bridge the gaps.
• Cooorinates processes, training, and other managerial activities with Biometrics leadership.
• Assesses and addresses potential compliance risks and ensures audit and inspection readiness, as applicable.

Qualifications

• PhD and Twelve Years’ Experience
• Preferred Qualifications: PhD degree in Biostatistics or equivalent and minimum 16 years of industry experience is preferred.

Pay

$302,005.00 - $390,830.00

Schedule

Full-time

Benefits

Company-sponsored medical, dental, vision, and life insurance plans*

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