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Job Description & How to Apply Below
Job Description
We are seeking an experienced Biostatistician with a passion for clinical development and advanced statistical methods. The successful candidate will support or lead one or more Phase I‑IV clinical studies, working embedded within a global pharmaceutical client and supported by Cytel. The role focuses on clinical trial design, analysis, and regulatory submissions.
Responsibilities
Providing statistical support to clinical studies
Participating in development of study protocols, study design discussions and sample size calculations
Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including dataset and TLG specifications
Performing statistical analyses and interpreting results
Preparing clinical study reports and integrated summaries for submissions
Communicating methodology and decisions to internal and external stakeholders
Ensuring compliance with ICH, Good Clinical Practice and electronic submission guidelines
Driving and supporting publication‑related activities and adhoc requests
Contributing to creation, maintenance, documentation and validation of programming tools, outputs and macros
Reviewing CRFs, edit check specifications and data validation plans
Providing review or authoring data transfer specifications for external vendor data
Collaborating with CROs, software vendors, clinical partners to meet project timelines and goals
Reviewing or authoring SOPs or work instructions related to statistical programming practices
Qualifications
Master’s degree in statistics or related discipline;
Ph.D. preferred
5+ years of supporting clinical trials in the pharmaceutical or biotechnology industry
Experience working for a CRO strongly desired
Experience with sample size calculation, protocol development, SAP, and preparing clinical study reports, including integrated summaries and safety reporting
Strong SAS programming skills for QCing outputs, efficacy/safety tables, and collaboration with programmers; knowledge of R desirable
Solid understanding of CDISC requirements for regulatory submissions
Experience generating and QCing ADaM specifications
Ability to build strong external and internal relationships and motivate team
Effective communication skills, able to explain methodology in lay terms
Seniority Level
Not Applicable
Employment Type
Full‑time
Job Function
Research, Analyst, and Information Technology
Industry
Pharmaceutical Manufacturing
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Position Requirements
10+ Years
work experience
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