Senior Manager, Biostatistics

About the role

The Senior Manager, Biostatistics works independently on clinical trial design, delivery and interpretation, pre‑clinical studies, regulatory submissions and commercialization. This individual performs and communicates technical analyses, guides less‑experienced staff, and develops creative statistical ideas and approaches. The role requires a competent individual contributor with excellent cross‑functional collaboration.

Responsibilities

• Provide statistical expertise for complex design and interpretation for preclinical or clinical programs, high‑level internal governance committees, regulatory submissions and/or commercialization.
• Analyze internal and external information, perform modelling and simulation to inform design decisions and develop decision criteria.
• Develop a Statistical Analysis Plan for complex studies and/or project deliveries.
• Coach and guide less‑experienced statisticians in producing analysis, supporting graphics and analysis tables for study reports, Global Medical Affairs studies or publications.
• Analyze, interpret, summarize and communicate results of complex studies.
• Contribute to regulatory submissions, including specification of overview documents and response to regulatory questions.
• Identify opportunities for modelling and simulation to improve study design.
• Identify opportunities to improve methodology and provide practical solutions for problems.
• Apply statistical methodology to improve process and delivery activities.
• Contribute to the development of best practice to improve quality, efficiency and effectiveness.
• Accountable for the quality of statistical work; provide discipline‑specific insight, constructive challenge and take ownership of development needs, seeking coaching or training opportunities.

Requirements

• MSc or PhD in Statistics, Mathematics (with substantial statistical component) or recognized equivalent.
• 1–2 years of experience in the pharmaceutical industry.
• Competent statistical programmer (SAS and R).
• Knowledge of key technical and regulatory requirements.
• Experience designing, analyzing and reporting preclinical or clinical studies in more than one setting.
• Strong communication, collaboration and team‑working skills.
• Experience and knowledge of statistical methods and applications in study design, analysis and interpretation.
• Flexible, well‑organized, and able to work well under pressure.
• Ability to use a computer, engage in phone/video/e‑mail communications, problem‑solve, collaborate, and maintain general availability during standard business hours.

Qualifications

• PhD in Statistics/Biostatistics is preferred.

Skills

• Statistical expertise applied to problem solving and quality focus.
• Proficiency in SAS and R programming.
• Ability to develop and communicate complex statistical analyses.
• Cross‑functional collaboration and coaching abilities.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holidays, and leaves).
• Health, dental, and vision coverage according to plan terms.
• Eligibility for short‑term incentive bonuses, equity‑based awards (for salaried roles), and commissions (for sales roles).

Pay

Annual base pay ranges from $119,848.00 to $157,300.50.