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Senior Statistical Programmer (Clinical Pharmacology)

Syneos Health
Syneos Health
5-8 years
preferred by company
Hyderabad
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Job Title: Senior Statistical Programmer (Clinical Pharmacology)

Location: Hyderabad, Telangana, 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 accomplished Senior Statistical Programmer (Clinical Pharmacology) to support global clinical development programs through advanced statistical programming, clinical pharmacology analytics, regulatory reporting, and biometrics leadership. This opportunity is ideal for professionals with expertise in SAS programming, SDTM, ADaM, TLF generation, PK/PD programming, validation programming, and regulatory statistical submissions.

The ideal candidate will lead end-to-end statistical programming activities for complex clinical studies, particularly within clinical pharmacology and early-phase development, while ensuring high-quality, compliant, and inspection-ready biometrics deliverables.

This role is highly suited for experienced statistical programmers seeking advanced leadership opportunities in global clinical research and drug development organizations.

Key Responsibilities

Statistical Programming & Clinical Reporting

  • Develop, validate, and maintain advanced statistical programming deliverables using SAS or equivalent statistical programming platforms.
  • Generate high-quality clinical reporting outputs including:
    • Summary tables
    • Data listings
    • Statistical figures / graphs
    • Derived datasets
    • Regulatory-ready analytical outputs
  • Translate Statistical Analysis Plans (SAPs) and programming specifications into efficient, accurate, and validated deliverables.
  • Ensure all programming outputs meet project timelines, sponsor expectations, and quality requirements.

Clinical Pharmacology & Early Phase Programming

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

CDISC Standards & Clinical Dataset Development

  • Lead end-to-end implementation of industry-standard clinical datasets including:
    • SDTM (Study Data Tabulation Model)
    • ADaM (Analysis Data Model)
  • Develop programming specifications, derived variables, analysis-ready datasets, and sponsor-compliant structures.
  • Review annotated CRFs, SAPs, mock shells, dataset specifications, and database structures for programming readiness.

TLF Development & Reporting Excellence

  • Design, program, and validate Tables, Listings, and Figures (TLFs) for interim analyses, final study reports, and sponsor submissions.
  • Maintain consistency, accuracy, traceability, and audit readiness across all statistical reporting deliverables.

Validation Programming & Quality Control

  • Perform validation programming, discrepancy resolution, debugging, reconciliation, and programming QC reviews.
  • Collaborate with programmers, biostatisticians, and study teams to resolve findings efficiently.
  • Maintain inspection-ready validation documentation, test evidence, and QC records.

Programming Leadership & Technical Oversight

  • Act as the lead statistical programmer for assigned clinical studies.
  • Direct and monitor programming activities of junior programmers and project contributors.
  • Review technical deliverables and provide proactive guidance to improve efficiency and reduce rework.
  • Anticipate programming risks and implement mitigation strategies early.

Project Management & Multi-Study Delivery

  • Manage timelines, priorities, and deliverables across multiple concurrent clinical studies.
  • Estimate programming effort, negotiate realistic timelines, and adapt to shifting project demands.
  • Communicate technical progress, blockers, risks, and mitigation plans clearly to stakeholders.

Cross-Functional Collaboration & Sponsor Interaction

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

Documentation, Compliance & Inspection Readiness

  • Maintain complete, organized, and inspection-ready documentation including:
    • Programming specifications
    • Validation documentation
    • QC records
    • Testing evidence
    • Study programming logs
    • Deliverable transfer records
  • Ensure compliance with ICH guidelines, SOPs, Work Instructions (WIs), and global clinical programming standards.