Senior Biostatistician

Clinical Outcomes Solutions

Senior Biostatistician at Cytel providing statistical support for clinical studies and regulatory submissions. Collaborating with pharmaceutical clients to drive innovative patient treatment programs.

Posted 7/22/2026full-timeRemote • 🇨🇴 ColombiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical support for clinical studies, including protocol development, statistical analysis plans, and regulatory compliance with FDA and CDISC standards. Strong communication skills are essential for presenting methodologies and collaborating with internal and external stakeholders.

Highest-signal resume keywords

Statistical Analysis Plans (SAP)SAS ProgrammingClinical Study ReportsCDISC RequirementsSample Size Calculation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical SupportData Review GuidelinesStatistical AnalysesEfficacy/Safety TablesADaM SpecificationsProtocol DevelopmentData Validation PlansIntegrated SummariesSample Size CalculationStatistical Programming

Soft Skills

Effective CommunicationRelationship BuildingTeam Motivation

Tools & Technologies

SASR Programming

Certifications & Qualifications

Master’s Degree in StatisticsPh.D. in Statistics (Preferred)

Industry Keywords

Clinical TrialsPharmaceutical IndustryBiotechnology IndustryCRO ExperienceOncology

About the role

Key responsibilities & impact

Providing statistical support to clinical studies
Participating in the development of study protocols, including participation in study design discussions and sample size calculations
Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
Performing statistical analyses and interpreting statistical results
Preparing clinical study reports, including integrated summaries for submissions
Utilizing your strong communication skills to present and explain the methodology and consequences of decisions
Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
Participate in the development of CRFs, edit check specifications, and data validation plans
Provide review and/or author data transfer specifications for external vendor data
Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Requirements

What you’ll need

Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
Experience working for a CRO is strongly desired.
Experience with oncology is a bonus.
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 & implementation of CDISC requirements for regulatory submissions.
Adept in ADaM specifications generation and QC of datasets.
The ability to build strong external & 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

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.