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Senior Statistical Programmer

5-8 years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Statistical Programmer – Hyderabad, India (Hybrid)

Updated: December 5, 2025
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25103396
Role Type: Full-time | Clinical Data & Biostatistics

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating clinical, medical, and commercial outcomes. Leveraging unique insights across clinical development, medical affairs, and commercial operations, Syneos Health ensures innovative therapies reach patients efficiently and safely.

We are seeking a Senior Statistical Programmer with extensive SAS programming and clinical data management expertise to join our Hyderabad team in a hybrid working model.


Role Overview

The Senior Statistical Programmer will develop and validate statistical programs to generate datasets, tables, listings, and figures for clinical trials, ensuring adherence to regulatory standards and sponsor requirements. The role includes team leadership, mentoring, and coordination with statisticians, project managers, and cross-functional clinical teams.


Key Responsibilities

Programming & Data Management

  • Develop and validate SAS programs to create analysis datasets, statistical tables, listings, and graphs according to the Statistical Analysis Plan (SAP) and programming specifications.

  • Perform validation programming and quality control checks, ensuring outputs meet internal and regulatory standards.

  • Identify and resolve programming discrepancies with statisticians and project team members.

Documentation & Compliance

  • Maintain complete, inspection-ready documentation including testing scripts, QC reports, and program logs.

  • Ensure compliance with SOPs, Work Instructions, ICH guidelines, and relevant regulatory requirements.

Project Management & Leadership

  • Manage multiple project timelines, set priorities, and adapt to schedule changes.

  • Act as the lead statistical programmer, reviewing SAPs, mock shells, annotated CRFs, and database designs.

  • Mentor junior programmers, provide training, and guide best practices for efficient programming.

  • Participate in sponsor meetings, study kick-offs, and project review discussions.

Collaboration & Communication

  • Conduct effective team meetings, distribute action items, and communicate project updates clearly.

  • Collaborate with internal and external stakeholders to support project deliverables.

  • Ensure timely and accurate completion of all programming tasks.

Additional Duties

  • Assist with ad hoc programming requests and other project-related responsibilities as required.

  • Minimal travel may be required.


Qualifications & Experience

  • Bachelor’s degree in Statistics, Computer Science, Life Sciences, or a related scientific discipline. Equivalent professional experience considered.

  • Minimum 5–8 years of hands-on experience in SAS programming within clinical trials or biostatistics.

  • Strong knowledge of CDISC standards (SDTM, ADaM) and clinical trial processes.

  • Experience in regulatory submissions and global clinical study environments is highly desirable.

  • Excellent written and verbal communication skills in English.

  • Proven ability to lead projects, manage multiple priorities, and mentor junior team members.


Why Syneos Health

  • Work with 94% of Novel FDA-Approved Drugs and 95% of EMA-Authorized Products over the past five years.

  • Join a global team of 29,000 employees across 110 countries, driving clinical innovation.

  • Thrive in an inclusive, collaborative, and career-focused culture with opportunities for skill development and progression.

Learn more at: www.syneoshealth.com


Additional Information

The listed responsibilities are not exhaustive. The company may assign additional duties as needed. Equivalent experience, education, or skills will be considered. Syneos Health complies with local employment laws and global regulations, including the Americans with Disabilities Act and the EU Equality Directive, providing reasonable workplace accommodations as appropriate.


Role Summary

The Senior Statistical Programmer develops high-quality clinical programming deliverables, supports global regulatory submissions, and ensures accurate and compliant statistical outputs. This role requires advanced technical expertise, leadership skills, and the ability to manage complex datasets for clinical trials across multiple phases.