Executive Director, Biostatistics – Medical Affairs

The Lotus Group LLC; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

People leadership

Strategic statistical leadership

Regulatory knowledge (GCP/ICH)

Cross-functional collaboration

Education

PhD in Biostatistics or equivalent

PhD with 12+ years of experience

Job description

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.