Principal Statistical Programmer

Clinical Outcomes Solutions

. Work independently with concept-level instruction and very little supervision .

Posted 10/14/2026full-timeRemote • IndiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in SAS programming and statistical analysis for clinical development, with a strong understanding of CDISC standards and regulatory requirements. Capable of independently managing programming deliverables and collaborating effectively with cross-functional teams.

Highest-signal resume keywords

SAS ProgrammingCDISC Standards (SDTM, ADaM, Define.xml)Regulatory SubmissionsStatistical AnalysisClinical Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingData AnalysisProgramming ProceduresData ValidationComplex ListingsDescriptive StatisticsInferential StatisticsGraph DevelopmentData Transfer SpecificationsCRF Development

Soft Skills

Written CommunicationVerbal CommunicationLeadershipCollaborationIndependence

Tools & Technologies

SASRPythonJavaShinyMarkdownUnix/LinuxGit

Industry Keywords

BiotechPharmaClinical TrialsFDA RegulationsGood Clinical PracticeMedical TerminologyClinical Development ProgramsBiometrics Team

Tech Stack

Tools & technologies

JavaLinuxPythonUnix

About the role

Key responsibilities & impact

Work independently with concept-level instruction and very little supervision
Track progress and provide expert technical support to team members
Work on clinical development programs across different therapeutic areas
Participate in overseeing CRO programmers to ensure consistent, high-quality data summaries
Implement reporting and analysis activities for Sponsor clinical trials
Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies
Develop SAS programs generating datasets, complex listings, tables, descriptive and inferential statistics, and complex graphs
Develop, validate, and maintain SAS and/or R programs for clinical development programs
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
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

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 regulation
Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities
Must be able to work independently
Outstanding written and verbal communication skills and strong leadership skills
Preferred: prior work experience with pharmacokinetic data and the neuroscience field
Preferred: proficiency in tools other than SAS, such as R, Python, Java, Shiny, Markdown, Unix/Linux, and git

Benefits

Comp & perks

Consistent training, development and support
Significant professional growth opportunities