Principal Statistical Programmer

Clinical Outcomes Solutions

. Work independently on clinical development programs across different therapeutic areas .

Posted 10/2/2026full-timeRemote • United States, CanadaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in SAS programming and statistical programming procedures tailored to clinical development, with a strong understanding of CDISC standards and FDA regulations. Capable of independently managing clinical development programs and collaborating effectively with cross-functional teams.

Highest-signal resume keywords

SAS ProgrammingCDISC StandardsStatistical Programming ProceduresRegulatory SubmissionsClinical Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingData AnalysisDataset GenerationComplex ListingsInferential StatisticsGraph DevelopmentData ValidationProgramming StandardsCRF DevelopmentData Transfer Specifications

Soft Skills

LeadershipCommunicationIndependenceCollaborationProblem-Solving

Tools & Technologies

RPythonJavaShinyMarkdownUnix/LinuxGit

Industry Keywords

BiotechPharmaClinical TrialsFDA RegulationsICH RegulationsMedical Device DevelopmentIntervention StudiesBiometrics TeamPharmacokinetic DataNeuroscience

Tech Stack

Tools & technologies

JavaLinuxPythonUnix

About the role

Key responsibilities & impact

Work independently on clinical development programs across different therapeutic areas
Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies
Develop SAS and/or R programs producing datasets, complex listings, tables, descriptive and standard inferential statistics, and complex graphs
Develop, validate, and maintain statistical programming programs tailored to clinical development needs
Oversee CRO statistical programming deliverables for multiple clinical studies
Support clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses
Follow FDA regulations, good clinical practice, and electronic-submission guidelines for clinical trial data reporting
Create, maintain, document, and validate standards for programming tools, outputs, and macros
Participate in developing CRFs, edit check specifications, and data validation plans
Review and/or author data transfer specifications for external vendor data
Collaborate with CROs, software vendors, clinical development partners, and internal functions to meet project timelines and goals
Review and/or author SOPs and work instructions related to statistical programming practices
Provide expert technical support to team members and track progress

Requirements

What you’ll need

At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team
Experience supporting drug development, medical device development, or intervention studies
Exceptional SAS programming skills and expertise in developing and implementing statistical programming procedures and processes in a clinical development environment
Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations
Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities
Ability to work independently
Outstanding written and verbal communication skills and strong leadership skills
Preferred: prior experience with pharmacokinetic data and neuroscience
Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, and git

Benefits

Comp & perks

Consistent training, development and support
Significant professional growth opportunities