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Prinicpal Biostatistician

0-2 years
₹30,00,000 – ₹40,00,000 per annum
10 Aug. 13, 2025
Job Description
Job Type: Full Time 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

Principal Biostatistician
Location: Remote, India

Company Overview:
Syneos Health® is a global leader in fully integrated biopharmaceutical solutions, accelerating customer success through innovative clinical, medical affairs, and commercial strategies. With a presence in 110 countries and over 29,000 employees, the company fosters an agile, collaborative culture that places patients and customers at the center of everything it does.

Why Join Syneos Health:

  • Career development and progression opportunities.

  • Supportive and engaged line management.

  • Technical and therapeutic area training.

  • Peer recognition and total rewards program.

  • Inclusive “Total Self” culture that values authenticity, diversity, and belonging.

Key Responsibilities:

  • Serve as a departmental resource, mentor biostatisticians, and oversee training initiatives.

  • Direct activities of biostatistics personnel to ensure timely, high-quality project completion.

  • Independently review statistical work from other team members.

  • Support statistical tasks across the full project lifecycle, from protocol to CSR.

  • Prepare or oversee Statistical Analysis Plans (SAPs) and mock-up displays for TLFs in collaboration with sponsors.

  • Act as Lead Biostatistician for protocols, randomization schedules, and clinical study report inputs.

  • Review SAS annotated CRFs, database designs, and related documentation to ensure data quality and protocol compliance.

  • Provide statistical programming specifications and support as required.

  • Lead complex or multiple projects, including regulatory submissions and integrated analyses.

  • Attend regulatory meetings or address agency queries regarding statistical results.

  • Manage timelines across multiple projects, adapting priorities as needed and escalating out-of-scope activities.

  • Participate in DSMB/DMC activities, including charter development and serving as an independent or voting statistician.

  • Ensure compliance with SOPs, WIs, ICH, and relevant regulatory guidelines.

  • Maintain inspection-ready project documentation and quality control records.

  • Contribute to business development through proposals, budgets, and sponsor meetings.

  • Perform additional duties as assigned, with minimal travel required.

Qualifications:

  • Advanced degree (Master’s or PhD) in Statistics, Biostatistics, or related field.

  • Extensive experience in clinical trial statistics, with proven leadership in managing multiple complex projects.

  • Proficiency in SAS programming and statistical methodology.

  • Strong interpersonal, communication, and mentoring skills.

  • Ability to manage timelines and deliverables in a fast-paced environment.

Salary Range: ₹30,00,000 – ₹40,00,000 per annum (estimated industry standard for senior-level remote biostatistics roles in India).