Principal Biostatistician – FSP

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

📋 Description

• Assist with Phase I-IV clinical trials

• Conduct ad-hoc or exploratory analyses to aid submissions or address Health Authority inquiries

• Offer statistical assistance for clinical trials

• Engage in the development of study protocols, contribute to study design discussions, and perform sample size calculations

• Review Case Report Forms (CRFs) and data review guidelines

• Create statistical analysis plans (SAPs), which include analysis dataset and TLG specifications

• Execute statistical analyses and interpret the results

• Compile clinical study reports, including integrated summaries for submissions

• Present and clarify methodologies and the implications of decisions

• Be fully integrated and dedicated to a global pharmaceutical client while being supported by Cytel

• Collaborate with clinical, regulatory, programming, internal, and external teams

⛳️ Requirements

• Master’s degree in statistics or a related field

• Over 3 years of experience supporting clinical trials in the Pharmaceutical or Biotechnology sector

• Prior experience with a Contract Research Organization (CRO) is highly preferred

• Proficient in sample size calculations, protocol concept and development, SAP creation, and preparation of clinical study reports, including integrated summaries for submissions

• Strong SAS programming skills for quality checking critical outputs, efficacy/safety tables, and collaborating closely with programmers

• Comprehensive understanding and application of CDISC standards for regulatory submissions

• Skilled in ADaM specifications generation and quality control of datasets

• Capability to foster robust external and internal relationships and inspire a regional or global team

• Excellent communication abilities; capable of conveying methodology and decision implications in simple terms

• Familiarity with R programming is an advantage

• Experience in regulatory matters is a plus

🏝️ Benefits

• Ongoing training, development, and support

• Significant opportunities for professional growth

• Various professional development opportunities