Senior Biostatistician, FSP

Clinical Outcomes Solutions

. Provide statistical support to clinical studies.

Posted 11/9/2026full-timeRemote • United Kingdom, Spain, Sweden, PolandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and clinical trial support, with a strong focus on FDA regulations, CDISC requirements, and effective communication of complex methodologies. Proficient in SAS programming and capable of collaborating with cross-functional teams to ensure successful project outcomes.

Highest-signal resume keywords

Statistical AnalysisSAS ProgrammingClinical Trial SupportCDISC RequirementsSample Size Calculation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical SupportSample Size CalculationStatistical Analysis PlansClinical Study ReportsADaM SpecificationsData Validation PlansEfficacy/Safety TablesProtocol DevelopmentData Transfer SpecificationsExploratory Analyses

Soft Skills

Effective CommunicationRelationship BuildingTeam Motivation

Tools & Technologies

SASR Programming

Industry Keywords

Clinical TrialsPharmaceutical IndustryBiotechnology IndustryCRO ExperienceGood Clinical PracticeElectronic Submission Guidelines

About the role

Key responsibilities & impact

Provide statistical support to clinical studies.
Participate in study protocol development, study design discussions, and sample size calculations.
Review CRFs and data review guidelines; develop statistical analysis plans, including analysis dataset and TLG specifications.
Perform statistical analyses and interpret statistical results.
Prepare clinical study reports, including integrated summaries for submissions.
Present and explain methodology and consequences of decisions.
Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines.
Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
Participate in development of CRFs, edit check specifications, and data validation plans.
Review and/or author data transfer specifications for external vendor data.
Collaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goals.
Review and/or author SOPs and work instructions related to statistical programming practices.
Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions.
Support medium-complexity clinical trials from design through archival and contribute to project-level activities.

Requirements

What you’ll need

Minimum of Bachelor's degree in statistics or a related discipline.
5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
Experience working for a CRO is strongly desired.
Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
Solid understanding and implementation of CDISC requirements for regulatory submissions.
Adept in ADaM specifications generation and QC of datasets.
Ability to build strong external and internal relationships and motivate a regional or global team.
Effective communicator able to explain methodology and consequences of decisions in lay terms.

Benefits

Comp & perks

Consistent training, development and support
Significant professional growth opportunities