Director, Biostatistics (Biopharmaceuticals)

TL;DR

Director, Biostatistics (Biopharmaceuticals): Providing statistical leadership and expertise throughout the drug development process with an accent on clinical trial design, analysis, and reporting. Focus on leading statistical innovation, engaging with global regulatory agencies, and ensuring high-quality statistical analyses for submission dossiers.

Location: Remote (Global)

Salary: $185,000–$252,500 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Lead statistical aspects of clinical development plans, studies, and regulatory interactions as a member of cross-functional teams.
• Manage timelines and oversee the quality of statistical analyses performed by internal teams or CROs.
• Drive statistical innovation activities, including innovative design, advanced analytics, and data visualization.
• Address complex analytical issues requiring advanced statistical thought and methodology.
• Foster collaboration across Biometrics and cross-functionally to ensure high-quality submission activities.
• Provide technical guidance and mentoring to junior statisticians.

Requirements

• PhD in Statistics or Biostatistics.
• 8+ years of experience within the pharmaceutical industry.
• Deep knowledge of the pharmaceutical environment and broad experience with multi-phase development.
• In-depth understanding of advanced statistical concepts and techniques applicable to Clinical Research.
• Proven track record of contributing to submission dossiers (IND, CTD) and interacting with regulatory agencies.
• Strong project management, interpersonal, and communication skills.

Nice to have

• Experience with NDAs and MAAs.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage, including mental health support and annual wellbeing reimbursement.
• Generous paid time off, fertility and family-forming benefits, and flexible work schedules.
• 401(k) plan with competitive company match, annual equity awards, and Employee Stock Purchase Plan (ESPP).
• Access to Company Learning Institute, LinkedIn Learning, leadership programs, and mentorship.
• Employee resource groups and opportunities for volunteering and community connection.