Principal Statistician, Biostatistics

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Provide statistical leadership for the design and reporting of clinical studies spanning Phase I to IV.

• Assist with regulatory submissions under the guidance of a senior statistician.

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

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

• Engage in data science and cross-functional discussions to enhance study designs, endpoints, and analytical approaches.

• Work collaboratively with study teams to adhere to timelines for studies and recurring reports.

• Aid in the development and execution of study protocols.

• Assess and validate data capture systems specific to the study.

• Create statistical programs for simulating trial design operating characteristics, conducting analyses, preparing data visualizations, and ensuring data accuracy and validity.

• Draft statistical analysis plans, execute data analysis and validation, and interpret results.

• Assist the project lead statistician.

• Prepare for and participate in regulatory agency meetings, addressing statistical inquiries.

• Collaborate closely with statistical programming colleagues.

• Supervise CRO guidelines and standards while reviewing and validating CRO deliverables.

• Partner with medical writers on clinical reports, integrated summaries, and various documents.

• Gain knowledge of drug development regulatory standards, including statistical contributions to marketing applications and adherence to CDISC SDTM and ADaM standards.

• Remain updated on advancements in statistics, drug development, and regulatory guidance.

⛳️ Requirements

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

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

• Familiarity with clinical trial design and analysis, including complex statistical techniques and models.

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

• Proficiency in using SAS and R.

• Awareness of relevant regulatory requirements and guidelines, such as ICH Guidelines.

• Knowledge of drug development regulations related to statistical analysis.

• Strong SAS and R programming capabilities.

• Understanding of CDISC models and standards.

• Exceptional writing, communication, interpersonal, and leadership abilities.

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

• High attention to detail and effective time management skills.

• Ability to work independently without close supervision.

• Knowledge of Bayesian and adaptive design is preferred.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Retirement savings plan.

• Flexible paid vacation.

• Opportunities for professional development, including attendance at conferences.