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Sr Biostatistician

3-5 years
Not Disclosed
10 July 30, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title

Sr Biostatistician – Remote (India)


Job Summary

Syneos Health is seeking an experienced Sr Biostatistician to support global clinical trials across various therapeutic areas. This is a remote position based in India, ideal for candidates with strong clinical data analysis skills, experience in statistical programming (SAS), and deep knowledge of ICH-GCP and regulatory guidelines. You will collaborate across multidisciplinary teams, contributing to study protocols, SAPs, and regulatory documentation, helping to deliver life-changing therapies to market faster.


Key Responsibilities

  • Develop Statistical Analysis Plans (SAPs) and mock-up displays for tables, listings, and figures

  • Support all statistical tasks from protocol through Clinical Study Report (CSR)

  • Review case report forms, database structures, and analysis datasets

  • Provide mentorship and coordinate with statistical programmers and other biostatisticians

  • Conduct QC and validation for all statistical deliverables

  • Represent the statistics team in internal and client-facing project meetings

  • Assist with Data Monitoring Committees and safety review boards

  • Contribute to regulatory responses and integrated statistical analysis

  • Support business development through proposals and client meetings

  • Ensure compliance with internal SOPs and ICH-GCP standards

  • Maintain audit-ready project documentation


Required Skills and Qualifications

  • Graduate degree in Biostatistics or a related discipline

  • Moderate experience in clinical trials (Phase I-IV) or equivalent

  • Strong proficiency in SAS and related statistical software

  • Sound understanding of ICH-GCP, statistical design, and regulatory standards

  • Hands-on experience with the full clinical study lifecycle from protocol to CSR

  • Strong verbal and written communication skills in English

  • Ability to manage multiple timelines and competing priorities

  • Experience with statistical QC, programming specs, and randomization


Perks and Benefits

  • Fully remote role based in India

  • Flexible work hours aligned with global project timelines

  • Exposure to global drug development pipelines

  • Cross-functional learning in a dynamic clinical environment

  • Career advancement and mentorship opportunities

  • Access to internal learning platforms and technical training

  • Part of a company involved in 94 percent of FDA-approved drugs in recent years


Company Description

Syneos Health is a leading global clinical and commercial biopharmaceutical solutions organization, working with top pharmaceutical and biotech companies. With operations in over 110 countries and involvement in 95 percent of EMA and 94 percent of FDA drug approvals, Syneos Health is accelerating drug development through clinical expertise and data-driven insights.


Work Mode

Remote (India)


Call to Action

Ready to shape the future of clinical trials with data-driven insights? Apply now to join Syneos Health as a Sr Biostatistician and contribute to delivering breakthrough treatments worldwide.
Click "Apply Now" to begin your journey in global biostatistics excellence.