Senior Principal Statistician, Biostatistics

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Oversee statistical aspects for individual studies, related studies, integrated summaries, and regulatory submissions.

• Create and report on Phase I to IV clinical trials.

• Offer statistical expertise for clinical development initiatives.

• Develop and implement statistical strategies, study 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 work performed by external statistics and programming vendors.

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

• Assist in the development and execution of study protocols.

• Evaluate and help validate data capture systems.

• Create statistical programs for clinical trial simulations, analyses, data presentations, and validation.

• Draft and review statistical analysis plans.

• Conduct and oversee data analysis and validation, interpreting the results.

• Prepare for and participate in meetings with regulatory agencies.

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

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

• Review and validate deliverables from CROs.

• Serve as a statistical subject matter expert for clinical reports, integrated summaries, and other documentation.

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

• Proficiency in clinical trial design and analysis, including advanced statistical methods and models.

• Strong understanding of statistical principles and methodologies, including statistical inference, hypothesis testing, estimates, parametric and non-parametric models and techniques, 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, drug development regulatory requirements, statistical contributions to marketing submissions, and CDISC standards.

• Understanding of drug development regulations related to statistical analysis.

• Proficient in SAS and R programming.

• Strong grasp of CDISC models and standards.

• Exceptional writing and communication abilities.

• Proven leadership skills and excellent interpersonal capabilities.

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

• Keen attention to detail.

• Capability to work independently with minimal supervision.

• Well-developed time management skills.

• Knowledge in the oncology or hematology therapeutic areas is preferred.

• Experience with Bayesian and adaptive design is preferred.

• Background in Phase I/II Oncology studies and Phase I healthy volunteer/clinical pharmacology studies for Neuroscience is preferred.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Retirement savings plan

• Flexible paid vacation