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Senior Statistical Programmer (Clinical Pharmacology)

Syneos Health
Syneos Health
5-8 years
preferred by company
Gurgaon, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Job Title: Senior Statistical Programmer (Clinical Pharmacology)

Location: Gurugram, Haryana, India (Hybrid)
Job Type: Full-Time
Experience Required: 5–8 Years (Freshers are not eligible)
Industry: Biostatistics / Statistical Programming / Clinical Pharmacology / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
Department: Biometrics / Statistical Programming / Clinical Data Sciences

About the Role
We are seeking a highly experienced and technically strong Senior Statistical Programmer (Clinical Pharmacology) to support advanced biometrics operations, clinical pharmacology studies, statistical programming delivery, and regulatory reporting across global drug development programs. This opportunity is ideal for professionals with expertise in SAS programming, SDTM, ADaM, TLF generation, PK/PD studies, clinical pharmacology programming, validation programming, and regulatory statistical submissions.

The ideal candidate will act as a statistical programming lead, managing complex end-to-end study deliverables, supporting clinical pharmacology programs, and ensuring delivery of high-quality, inspection-ready programming outputs aligned with sponsor and regulatory expectations.

This role is highly suited for experienced biometrics professionals looking to grow into technical leadership roles in global clinical research environments.

Key Responsibilities

Statistical Programming & Clinical Study Deliverables

  • Develop advanced statistical programming outputs using SAS or equivalent statistical programming platforms for global clinical studies.
  • Generate and validate:
    • Summary tables
    • Data listings
    • Graphs / figures
    • Derived analysis datasets
    • Clinical reporting outputs
  • Translate Statistical Analysis Plans (SAPs) and programming specifications into validated, regulator-ready deliverables.
  • Ensure programming outputs meet sponsor expectations, quality standards, and study timelines.

Clinical Pharmacology & Early Phase Study Programming

  • Support Clinical Pharmacology studies, including early-phase development programs and specialized analytical workflows.
  • Work with PK/PD trial datasets, pharmacokinetic analyses, pharmacodynamic reporting, and clinical pharmacology data structures.
  • Support study-specific analytical programming for early development clinical trials.

CDISC Standards & Clinical Dataset Development

  • Lead end-to-end dataset programming using global data standards including:
    • SDTM (Study Data Tabulation Model)
    • ADaM (Analysis Data Model)
  • Support dataset specifications, derived variable creation, sponsor-specific requirements, and regulatory submission standards.
  • Review annotated CRFs, database structures, and programming specifications for implementation accuracy.

TLF Generation & Reporting Excellence

  • Create and validate Tables, Listings, and Figures (TLFs) for interim analysis, final reporting, sponsor review, and regulatory documentation.
  • Ensure consistency, accuracy, and quality across statistical reporting deliverables.

Validation Programming & Quality Control

  • Perform validation programming, discrepancy investigation, reconciliation, debugging, and quality control activities.
  • Work with programmers, biostatisticians, and project teams to resolve technical findings efficiently.
  • Maintain high-quality testing, verification, QC, and inspection-ready documentation.

Programming Leadership & Study Ownership

  • Act as the lead statistical programmer for assigned clinical studies.
  • Direct programming activities for junior programmers and monitor progress against project timelines.
  • Review programming deliverables, specifications, dataset logic, and technical outputs.
  • Provide proactive technical guidance that improves efficiency and reduces rework.

Project Management & Multi-Study Delivery

  • Manage programming activities across multiple concurrent studies and deliverables.
  • Negotiate timelines, estimate effort, prioritize workstreams, and adapt to changing project requirements.
  • Communicate progress, risks, technical issues, and mitigation plans clearly to stakeholders.

Cross-Functional Collaboration & Sponsor Interaction

  • Collaborate closely with:
    • Biostatistics teams
    • Clinical Data Management
    • Clinical Operations
    • Medical Writing teams
    • Sponsor stakeholders
    • Regulatory teams
  • Participate in sponsor meetings, project kickoffs, technical planning sessions, and bid defense discussions as statistical programming representative.

Documentation, Compliance & Inspection Readiness

  • Maintain complete, organized, and inspection-ready programming documentation including:
    • Specifications
    • Validation records
    • QC documentation
    • Programming logs
    • Testing evidence
  • Ensure compliance with ICH guidelines, SOPs, Work Instructions (WIs), and global regulatory programming expectations.

Training, Mentorship & Team Development

  • Mentor junior statistical programmers through training, work review, technical feedback, and onboarding support.
  • Contribute to development of internal training materials and programming capability building initiatives.
  • Support knowledge sharing and technical excellence culture within the biometrics organization.

Required Qualifications

  • Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, Biotechnology, Pharmacy, or related scientific/quantitative disciplines.
  • Minimum 5–8 years of hands-on statistical programming experience in clinical research, CRO, pharmaceutical, or biotechnology environments.
  • Strong end-to-end expertise in:
    • SAS programming
    • SDTM
    • ADaM
    • TLF generation
    • Validation programming
    • Clinical trial reporting
  • Exposure to Early Phase studies / PK-PD clinical pharmacology programs preferred.
  • Strong knowledge of clinical trial data standards, biometrics workflows, and regulatory submission programming.
  • Excellent written and verbal English communication skills.
  • Ability to manage multiple projects in fast-paced global environments.