Principal Statistician

Worldwide Clinical Trials

. Lead and contribute to development and implementation of Statistical Analysis Plans .

Posted 10/12/2026full-timeKochi • IndiaLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and clinical trial design, with a strong focus on SAS programming and regulatory compliance. Capable of providing statistical consultancy and leadership while managing multiple projects across various therapeutic areas.

Highest-signal resume keywords

SAS ProgrammingStatistical Analysis PlansRegulatory Standards KnowledgeStatistical ConsultancyClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisClinical Trial DesignData ProcessingStatistical ReportingStatistical ProtocolsDerived DatasetsSDTM/ADaM DatasetsTables and Figures PreparationQuality AssuranceProject Management

Soft Skills

Time ManagementCommunication SkillsOrganizational SkillsTeam CollaborationFacilitation Skills

Tools & Technologies

SASMicrosoft OfficeWindowsPCs

Industry Keywords

ICH StandardsFDA Quality System Regulation21 CFR Part 11Clinical ResearchStatistical Methodologies

About the role

Key responsibilities & impact

Lead and contribute to development and implementation of Statistical Analysis Plans
Provide internal and external statistical consultancy
Review study designs, analysis plans, and reports
Contribute to clinical-trial design, statistical protocol sections, randomization methodology, and Statistical Analysis Plans
Specify and review tables, figures, listing shells, and derived dataset specifications
Prepare final reports, including tables, figures, listings, and report writing
Develop, test, and run SAS programs for clinical-study statistical analyses, including derived datasets, SDTM/ADaM datasets, tables, figures, listings, and validation
Manage ad hoc data-summary requests during trials
Extract summaries, data listings, and study datasets from systems during trials
Identify system and process improvements and implement solutions for clinical-study data processing and reporting
Contribute statistical content to publication manuscripts
Manage statistics support for projects or sponsor programs through timely statistical consultancy and support
Provide consultancy, mentoring, and guidance to statisticians on methodological issues
Ensure compliance with WCT, sponsor quality systems, ICH standards, and FDA Quality System Regulation including 21 CFR Part 11
Liaise with internal departments, sponsors, and third parties on statistical issues and reporting requirements
Represent the statistics function in sponsor meetings, vendor meetings, and conferences
Apply current statistical-methods, regulatory, and software-application knowledge
Contribute to statistical design and analysis policies
Review budgets and identify out-of-scope or unbudgeted work
Assist with quality assurance and audit requirements
Support department leadership with other assigned duties

Requirements

What you’ll need

Appropriate degree and minimum relevant experience: BSc/8 years, MSc/6 years, or PhD/4 years
Hands-on expert-level project statistician experienced in providing statistical leadership to projects
Broad statistical applications experience across all phases of clinical research
Thorough knowledge of regulatory standards and exposure to regulatory interactions
Thorough knowledge of SAS; knowledge of other software applications is a plus
Computer literacy and numeracy, with ability to adapt to various computer systems
Consultancy and facilitation skills
Excellent time-management skills and ability to develop, follow, and direct project plans
Working knowledge of PCs, Windows, and Microsoft Office
Good oral and written communication and organizational skills
Ability to communicate effectively in English
Ability to prioritize and handle multiple projects simultaneously
Flexible approach, sound independent judgment, and initiative
Experience working within a team environment
Experience across multiple therapeutic areas

Benefits

Comp & perks

Equal employment opportunity commitment
Diverse and inclusive workplace
Supportive and collaborative teams
Accessible leadership
Opportunities to contribute to professional development through consultancy, mentoring, and guidance
Flexible approach to managing multiple projects