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Senior Statistical Programmer- Hybrid (Hyderabad & Gurugram)

1+ years
Not Disclosed
10 Dec. 5, 2025
Job Description
Job Type: Full Time 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 – Hybrid (Hyderabad & Gurugram)

Location: Hyderabad, India
Job ID: 25103401
Updated: Today
Company: Syneos Health

About the Role

Syneos Health is a fully integrated biopharmaceutical solutions organization supporting global clinical development and commercialization. As a Senior Statistical Programmer, you will contribute to high-quality clinical data analysis by developing, validating, and delivering statistical programming outputs aligned with CDISC standards. This role requires strong expertise in clinical SAS programming, data standards, and end-to-end clinical trial support across phases and therapeutic areas.

This is a hybrid position based in Hyderabad or Gurugram, offering collaboration opportunities with global cross-functional teams.


Key Responsibilities

  • Provide advanced statistical programming support for clinical trials, including SDTM, ADaM, and TFL development.

  • Perform CRF annotations, write SDTM specifications, manage vendor data, and support e-submission deliverables including DEFINE, SDRG, and ADRG.

  • Lead programming activities for multiple studies with strong ownership of timelines, quality, and documentation.

  • Conduct SME-level reviews of programming outputs, ensuring accuracy, compliance, and audit readiness.

  • Coordinate with biostatisticians, data managers, and cross-functional stakeholders to finalize study specifications.

  • Contribute to safety and efficacy analyses across Phase I–IV clinical trials.

  • Support therapeutic areas such as oncology, neurology, and other domains as required.

  • Demonstrate proactive issue management, risk assessment, and effective communication with internal and external partners.

  • Work effectively in matrix environments and with FSP (Functional Service Provider) models.

  • Maintain high-level knowledge of CDISC standards, emerging regulatory requirements, and evolving programming methodologies.


Experience Required

  • Minimum 5 years of experience in clinical SAS/statistical programming within the pharmaceutical or CRO industry.

  • Minimum 1 year of proven experience leading clinical programming activities across multiple studies.

  • Strong hands-on expertise in SDTM, ADaM, and TFLs with thorough understanding of CDISC standards.

  • Working experience across clinical phases: Phase I, II, III, and IV (dedicated Phase I experience preferred but not mandatory).

  • Experience with therapeutic areas including Oncology, Neurology, or related fields.

  • Exposure to vendor data handling and e-submissions (DEFINE, SDRG, ADRG).

  • Prior experience in an FSO/FSP environment preferred.


Qualifications

  • Graduate degree in statistics, life sciences, computer science, or a related scientific discipline.

  • In absence of a degree, equivalent professional experience will be considered.

  • Advanced programming skills in SAS; experience with additional languages such as R, PL/SQL, or other analytic tools is beneficial.

  • Excellent command of written and spoken English.

  • Strong analytical, organizational, and communication skills.

  • Ability to work in fast-paced, dynamic, and matrix-driven environments.


About Syneos Health

Over the past five years, Syneos Health has supported:

  • 94% of all novel FDA-approved drugs

  • 95% of EMA-authorized products

  • More than 200 global studies across 73,000 sites and over 675,000 clinical trial participants

The organization is committed to continuous learning, professional growth, and building an inclusive work culture where diverse perspectives contribute to meaningful outcomes.

Learn more at the Syneos Health website.


Additional Information

Responsibilities listed are not exhaustive. The company may assign additional duties as necessary. Syneos Health complies with all applicable regulations, including equal opportunity, disability accommodations, and global employment standards.


Summary

The Senior Statistical Programmer plays a critical role in statistical programming deliverables, data transformation, analysis dataset development, and process optimization. This position contributes directly to study execution, regulatory submissions, and high-quality clinical outputs while ensuring global standards and timelines are met.