Senior Principal Statistician

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Serve as the leading statistician for individual studies, related studies, integrated summaries, and regulatory submissions.

• Design and report on clinical studies spanning Phase I to IV.

• Oversee all statistical components of study design, analysis, validation, and documentation.

• Create and implement statistical strategies, designs, and analyses for clinical trials.

• Collaborate with teams in clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.

• Supervise tasks conducted by external statistics and programming vendors.

• Engage in departmental and cross-functional meetings to enhance study designs, endpoints, and analysis methodologies.

• Assist in the development and execution of study protocols.

• Review and contribute to data capture systems and take part in validation processes.

• Create statistical programs to simulate the operational characteristics of clinical trial designs, execute analyses, prepare data visualizations, and ensure data accuracy and analysis validity.

• Compose and evaluate statistical analysis plans.

• Conduct and oversee data analyses and validations, interpreting the results.

• Prepare for and participate in meetings with regulatory agencies.

• Develop, implement, and uphold department standards and practices.

• Assess CRO timelines and analysis plans for promptness and quality.

• Review and verify CRO deliverables.

• Act as a statistical subject matter expert for clinical reports, integrated summaries, and other relevant documents.

• Address statistical inquiries from regulatory bodies.

⛳️ Requirements

• MS or MPH in statistics, mathematics, or a related field with a statistical emphasis and over 4 years of experience in the pharmaceutical or biotechnology sector.

• PhD in statistics, mathematics, or a related field with a statistical emphasis and more than 2 years of experience in the pharmaceutical or biotechnology sector.

• Proficient understanding of clinical trial design and analysis, including advanced statistical methods and models.

• Comprehensive knowledge of statistical principles and methodologies, statistical inference, hypothesis testing, estimates, parametric and non-parametric models, sample size calculations, experimental design, and Phase II-IV clinical trial data analysis.

• Experience with SAS and R programming.

• Familiarity with relevant regulatory requirements and guidelines, including ICH Guidelines and drug development regulations.

• Understanding of statistical contributions to marketing applications and CDISC standards.

• Knowledge of drug development regulations relevant to statistical analysis.

• Advanced programming skills in SAS and R.

• Strong grasp of CDISC models and standards.

• Exceptional writing and communication skills.

• Proven leadership skills and excellent interpersonal abilities.

• Capacity to thrive in a fast-paced, adaptable, team-oriented environment.

• Keen attention to detail.

• Ability to work independently with minimal supervision.

• Well-honed time management skills.

• Preferred knowledge of the oncology or hematology therapeutic area.

• Experience with Bayesian and adaptive design methods is preferred.

🏝️ Benefits

• Discretionary annual cash bonuses or incentive compensation.

• Discretionary equity grants.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401k retirement savings plan.

• Flexible paid vacation policy.