Principal Statistician, Biostatistics

Brief Description

• The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. Responsible for statistical aspects of study design, study analysis/validation, and study documentation.
• Develop and execute statistical strategy, design, and analyses for clinical trials; oversee work by statistics and programming external vendors.
• Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.

• Participate in department and cross‑functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
• Collaborate with study teams to meet study and recurring report timelines.
• Support development and implementation of study protocols.
• Review and provide input to study‑specific data capture systems; participate in their validation.
• Develop statistical programs to simulate trial operating characteristics, perform analysis, prepare data displays, and verify accuracy/validity of programmed analyses.
• Write statistical analysis plans; perform data analysis/validation and interpret analyses.
• Support the project lead statistician.
• Prepare for and attend regulatory agency meetings; respond to statistical questions.
• Work closely with statistical programming colleagues.
• Monitor CRO guidelines/standards; review and validate CRO deliverables.
• Collaborate with medical writers on clinical reports, integrated summaries, and other documents.
• Learn and apply drug development regulatory requirements related to statistics (including marketing applications and CDISC SDTM/ADaM).
• Stay current via literature review, conference attendance, and professional development.
• Other work as assigned by line manager.

• Clinical trial design and analysis, including complex statistical methods/models; statistical inference, hypothesis testing, estimates; parametric/non‑parametric methods; sample size calculations; experimental design;
  Phase II–IV data analysis.
• SAS and R experience (other languages/applications a plus).
• Knowledge of applicable regulatory requirements/guidelines (e.g., ICH).
• Ability to work in a fast‑paced, flexible, team‑oriented environment.
• Strong written/verbal interpersonal and communication skills.
• Strong attention to detail; flexible, positive, creative thinker; effective time management; able to work without close supervision.

• MS or MPH in statistics, mathematics, or related field with statistical focus and > 2 years pharmaceutical/biotech industry experience.
• PhD in statistics, mathematics, or related field with statistical focus and < 2 years pharmaceutical/biotech industry experience.
• Knowledge of drug development regulations pertinent to statistical analysis.
• Bayesian and adaptive design knowledge preferred.
• Proficient SAS & R; understanding of CDISC models/standards.
• Excellent writing/communication skills; demonstrated leadership and interpersonal skills.

• Eligible for discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
• Medical, dental, and vision insurance; 401(k); flexible paid vacation.

If a current Jazz employee: apply via the Internal Career site.