Director of Biostatistics

Mantell Associates are thrilled to have partnered with a leading Biotech who are seeking a Director of Biostatistics to join them.

Director of Biostatistics – Responsibilities:

• Lead the statistical strategy for rare disease clinical trials, from early-phase development through regulatory submission.
• Design and implement statistical methodologies to address complex challenges in rare disease clinical trials.
• Provide statistical input into study designs, including randomization schemes, sample size calculations, and analysis plans.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and medical affairs, to ensure alignment on data needs and strategy.
• Review and interpret statistical results, presenting findings to senior leadership, clinical development teams, and regulatory agencies.
• Ensure high-quality and accurate biostatistical deliverables, including clinical study reports, regulatory submissions, and publications.
• Stay current on advancements in biostatistical methodologies, regulatory guidance, and rare disease therapeutic areas.
• Mentor and manage a team of biostatisticians, providing leadership and career development.

Director of Biostatistics – Requirements:

• PhD or Master’s degree in Biostatistics, Statistics, Mathematics, or a related field.
• Minimum of 8 years of experience in biostatistics, with at least 4 years in a leadership role within clinical research.
• Experience designing and analyzing clinical trials for rare diseases or similar therapeutic areas.
• Expertise in statistical software (e.g., SAS, R) and clinical trial methodologies.
• Strong understanding of regulatory guidelines and submission processes, including FDA and EMA requirements.
• Excellent communication skills, with the ability to convey complex statistical concepts to both technical and non-technical stakeholders.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.