Principal Statistical Programmer

Worldwide Clinical Trials

. Lead and take full accountability for multiple complex studies, including submissions and integration projects .

Posted 10/12/2026full-timeKochi • IndiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced SAS programming skills and expertise in CDISC standards, ensuring compliance with GCP and FDA regulations. Capable of leading complex studies and managing project delivery while fostering team development and quality improvement initiatives.

Highest-signal resume keywords

Advanced SAS Programming SkillsExpertise in CDISC StandardsHands-On Project Statistical Programming ExperienceCompliance with GCP StandardsLeadership and Team Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS/MacroProc ReportODSSAS/GraphProc SQLSAS/STATStatistical ProgrammingData ManagementQuality AssuranceValidation Documentation

Soft Skills

AdaptabilityProject ManagementTeam LeadershipCommunication

Industry Keywords

CDISCSDTMADaMDefine.xmlCRT ComponentsGCP StandardsFDA Quality System Regulation21 CFR Part 11

Tech Stack

Tools & technologies

Google Cloud PlatformSQL

About the role

Key responsibilities & impact

Lead and take full accountability for multiple complex studies, including submissions and integration projects
Manage sponsor expectations and coordinate with Biostatistical Operations leadership to maintain resources and meet delivery deadlines
Lead large study teams, ensuring activities are delivered on time and to quality standards
Manage competing priorities and adapt to change
Own quality and process improvement initiatives and diverse project tasks
Implement CDISC standards across multiple studies
Design and deploy Biostatistical delivery process improvements using advanced SAS knowledge and alternative technical solutions
Provide expertise and consultancy on regulatory submission requirements
Provide leadership and development for team members across the department
Support statistics reporting through table, figure and listing shells, derived dataset specifications, report documents, and tabulations
Maintain program and validation documentation
Lead development and maintenance of in-house programming standards
Validate software and test SAS macros, maintaining validation and testing documentation
Assist with Quality Assurance and audit requirements
Perform all activities in compliance with WCT and sponsor quality systems, GCP standards, and FDA Quality System Regulation, including 21 CFR Part 11
Perform other duties as assigned

Requirements

What you’ll need

University Degree is required
Minimum 8 years of previous related experience
Advanced SAS programming skills
Expert knowledge in SAS/Macro, Proc Report and ODS
Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT
Hands-on expert-level project statistical programming experience
Expertise in CDISC standards, including SDTM, ADaM, Define.xml, and CRT components
Expertise in upstream Data Management and downstream Medical Writing processes
Computer literacy and numeracy
Willingness to adapt to various computer systems
Compliance with relevant GCP standards and FDA Quality System Regulation, including 21 CFR Part 11

Benefits

Comp & perks

Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
Diverse and inclusive work environment
Supportive and collaborative teams
Professional development and leadership opportunities