Senior Biostatistician, FSP

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

📋 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 guidelines for data review.

• Create statistical analysis plans, which encompass analysis datasets and TLG specifications.

• Conduct statistical analyses and interpret the resultant statistics.

• Compile clinical study reports, including integrated summaries for regulatory submissions.

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

• Comprehend and adhere to FDA regulations regarding clinical trial data reporting, including good clinical practices and electronic submission guidelines.

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

• Take part in the development of CRFs, specifications for edit checks, and plans for data validation.

• Review and/or author specifications for data transfers from external vendors.

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

• Review and/or draft SOPs and work instructions pertaining to statistical programming practices.

• Conduct ad-hoc or exploratory analyses that support submissions or inquiries from health authorities.

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

⛳️ Requirements

• Master’s degree in statistics or a related field.

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

• Experience with a CRO is highly preferred.

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

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

• Familiarity with R programming is advantageous.

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

• Skilled in generating ADaM specifications and quality checking datasets.

• Capable of establishing robust relationships both externally and internally and inspiring a regional or global team.

• Strong communication skills; able to convey methodologies and the implications of decisions in easily understandable terms.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional advancement.

• Autonomy and responsibility in your role.

• Dedicated work with a sponsor embedded within a pharmaceutical client.

• Support from Cytel.

• Opportunities for professional development.