Senior Biostatistician, FSP

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Deliver statistical assistance for clinical studies.

• Engage in the development of study protocols, discussions on study design, and calculations for sample sizes.

• Evaluate CRFs and data review guidelines; create statistical analysis plans, which include analysis datasets and TLG specifications.

• Conduct statistical analyses and interpret the results obtained.

• Compile clinical study reports, including comprehensive summaries for submissions.

• Present and clarify methodologies and the implications of decisions made.

• Comprehend and adhere to FDA regulations that impact clinical trial data reporting, including good clinical practice and electronic submission guidelines.

• Assist in the creation, upkeep, documentation, and validation of standards for programming tools, outputs, and macros.

• Take part in the development of CRFs, edit check specifications, and data validation strategies.

• Review and/or draft data transfer specifications for data from external vendors.

• Collaborate with both internal and external entities, such as CROs, software vendors, and clinical development partners, to achieve project timelines and objectives.

• Review and/or author SOPs and work instructions pertinent to statistical programming practices.

• Conduct ad-hoc or exploratory analyses to support submissions or inquiries from Health Authorities.

• Provide support for medium-complexity clinical trials from their design phase to archival, while contributing to project-level activities.

⛳️ Requirements

• A minimum of a Bachelor's degree in statistics or a related field.

• Over 5 years of experience supporting clinical trials in the Pharmaceutical or Biotechnology sector.

• Experience working with a CRO is highly preferred.

• Proficient in sample size calculation, protocol concept development, protocol drafting, SAP preparation, and compiling clinical study reports, including comprehensive summaries for submissions.

• Strong SAS programming skills for quality control of critical outputs, Efficacy/Safety tables, and collaboration with Programmers. Familiarity with R programming is advantageous.

• Comprehensive understanding and application of CDISC requirements for regulatory submissions.

• Skilled in generating ADaM specifications and quality checking datasets.

• Capable of establishing robust relationships with both external and internal stakeholders while motivating a regional or global team.

• Strong communicator able to articulate methodologies and the implications of decisions in layman’s terms.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.