Executive Director Medical Affairs

The Lotus Group LLC; New Jersey; Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

The Lotus Group LLC seeks an Executive Director of Biostatistics for Medical Affairs to lead the Biostatistics function across its portfolio. This role will build and scale a high-performing Biostatistics team, providing strategic statistical input and ensuring rigorous methodology across studies.

The leader will oversee internal and external resources, set SOPs, and drive innovative statistical approaches while collaborating with RWE/HEOR and other functions to support evidence generation.

Qualifications

• PhD with 12+ years of relevant experience.
• Preferred: PhD in Biostatistics or equivalent with 16+ years of industry experience.

Responsabilités

• Provide statistical oversight of Medical Affairs biostatistics activities and external consultants.
• Provide strategic statistical input for Medical Affairs studies and evidence-generation activities.
• Oversee technical and operational statistical activities through management of internal and external resources.
• Build and lead the Medical Affairs Biostatistics team, including staffing plans and operating model.
• Coordinate with Biometrics leadership and ensure audit and inspection readiness.

Connaissances

People leadership

Strategic statistical leadership

Regulatory knowledge (GCP/ICH)

Cross-functional collaboration

Formation

PhD in Biostatistics or equivalent

PhD with 12+ years of experience

Description du poste

Executive Director, Biostatistics – Medical Affairs

About the Company

Our client is a global biopharmaceutical company with a long track record of developing and delivering innovative therapies across multiple therapeutic areas, including virology, inflammation, and oncology. The organization is committed to tackling major public health challenges and values collaboration, scientific rigor, and strong people leadership.

Role Overview

Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Medical Affairs will lead the Biostatistics function for Medical Affairs studies across all therapeutic areas. This leader will build, scale, and lead a high-performing Biostatistics team supporting the Medical Affairs portfolio. The ideal candidate has a proven track record of functional leadership, strategic judgment in applying both innovative and pragmatic statistics, and demonstrated excellence in people management and development.

Responsibilities

• Provide statistical oversight of all biostatisticians supporting Medical Affairs and all biostatistics-related work by internal biostatisticians and external consultants.
• Provide strategic statistical input for Medical Affairs studies, observational studies, and broader evidence-generation activities across the portfolio, in partnership with functions including RWE and HEOR.
• Oversee and contribute to all technical and operational statistical activities through management of internal and external resources.
• Build, develop, and lead the Medical Affairs Biostatistics team, including team structure, staffing plans, capability development, and operating model.
• Anticipate emerging projects and work with senior management on staffing plans; assign and manage resources according to priorities and business strategy.
• Negotiate project timelines across programs with competing priorities, coordinating limited resources to deliver quality work on time.
• Develop and ensure adherence to SOPs and departmental standards for the conduct of Medical Affairs studies, statistical methodology, data analysis, and interpretation.
• Champion the development and training of decision-enabling statistical tools, and explore more efficient and innovative statistical approaches.
• Ensure the scientific integrity of statistical methods and maintain rigorous statistical standards across the portfolio.
• Empower biostatisticians to exercise good judgment, take a data-driven approach, and follow best practices to become accountable decision-makers.
• Participate in cross-functional leadership meetings and represent the Biostatistics function.
• Set clear expectations for biostatisticians supporting Medical Affairs, including delegation, decision-making, and communication, and provide ongoing constructive feedback.
• Develop talent plans to retain top performers, anticipate capability gaps, and use internal and external resources to close them.
• Coordinate processes, training, and managerial activities with Biometrics leadership; assess compliance risks and ensure audit and inspection readiness.
• Provide leadership support beyond the core Medical Affairs portfolio as organizational needs evolve.

Capabilities and Skills

• Excellent verbal and written communication, negotiation, and interpersonal skills.
• In-depth knowledge of the drug development process, with strong commitment to GCP, ICH guidelines, and regulatory requirements.
• Proven ability to supervise team leads who manage people, and to delegate, coach, and develop team members.
• Ability to give teams a clear decision-making framework that connects present actions to future outcomes.
• Excellent judgment and problem-solving in complex situations, including making sound evidence-based decisions with limited information.
• Ability to lead departmental strategic initiatives and to recommend and implement new processes that improve efficiency and quality.
• Ability to integrate planning across departments, drive change, and influence decision-making.
• Ability to advise and influence senior leadership on biostatistics strategy and functional issues with business impact, including using competitive intelligence to shape evidence-generation and development strategy.
• Experience in Medical Affairs, observational studies, and/or broader evidence generation is preferred.

Qualifications

• Basic: PhD with 12+ years of relevant experience.
• Preferred: PhD in Biostatistics or equivalent with 16+ years of industry experience.

People Leadership Expectations

• Create Inclusion: Model inclusion and embed the value of diverse teams in how the team is managed.
• Develop Talent: Understand each employee’s skills, aspirations, and potential, and coach on current performance and future growth.
• Empower Teams: Align team goals with organizational objectives, hold the team accountable, remove barriers, and connect the team to the broader organization.