Director, Biostatistics

Responsibilities:

• Lead product-level biostatistics tasks including regulatory interactions and filings, ensuring statistical integrity.
• Contribute to study design, sample size determination, and author/review statistical analysis plans and TFL specifications.
• Mentor junior team members and collaborate cross-functionally to meet product deliverables and timelines.

Requirements:

• PhD in Statistics or Biostatistics with min 8 years (or 11 years for Masters) of post-graduate clinical trials experience in pharma.
• Experienced in NDA/BLA/MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction.
• Familiar with ICH guidelines and FDA/EMA guidance; proficiency in SAS and R, preferably with CDISC knowledge.

Benefits:

• Generous vacation time and public holidays.
• Long term incentive and employee stock purchase plans.
• Employee wellbeing benefits, fitness reimbursement, tuition sponsoring, and professional development plans.