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Sr Biostatistician

0-2 years
Not Disclosed
10 May 2, 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:

Senior Biostatistician


Company:

Syneos Health
A global biopharmaceutical solutions organization supporting drug development and commercialization. Operates in over 110 countries, with expertise in clinical development, medical affairs, and commercialization services.


Location:

India (Remote/Flexible)


Job ID:

25003325


Updated:

May 2, 2025 (Today)


Job Summary:

The Senior Biostatistician provides statistical leadership and support across clinical studies, ensuring high-quality deliverables throughout the project lifecycle. The role includes protocol development, SAP writing, data analysis oversight, and team coordination.


Key Responsibilities:

  • Manage statistical tasks from study protocol through to CSR.

  • Prepare SAPs and develop mock-ups for tables, listings, and figures.

  • Coordinate work of biostatistics and programming staff on projects.

  • Review CRFs, database design, and statistical deliverables.

  • Provide verification and quality control of statistical outputs.

  • Serve as the biostatistical representative on cross-functional teams.

  • Oversee scheduling, timelines, and proactively communicate risks.

  • Provide programming support and contribute to integrated analyses.

  • Participate in DMC/DSMB activities as non-voting biostatistician.

  • Maintain organized documentation ensuring inspection readiness.

  • Support business development activities including proposals and bid defenses.

  • Mentor junior biostatistics team members.


Qualifications:

Required:

  • Graduate degree in Biostatistics or related field.

  • Moderate experience in clinical trials or equivalent background.

  • Proficiency in statistical programming (e.g., SAS).

  • Understanding of statistical design, analysis, ICH guidelines, and regulatory processes.

  • Strong communication skills in English (written and spoken).


Preferred Skills:

  • Experience across full clinical trial lifecycle.

  • Ability to manage multiple projects simultaneously.

  • Exposure to regulatory agency interactions is a plus.


About Syneos Health:

Syneos Health has been involved in 94% of novel FDA drug approvals and 95% of EMA-authorized products over the last five years. With a commitment to inclusion, innovation, and career development, the company fosters a culture where people thrive.