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Principal Biostatistician

8+ years
Not Disclosed
10 June 16, 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

 

Job Summary:

Syneos Health, a global biopharmaceutical solutions organization, is hiring for a Principal Biostatistician in Pune, India. This pivotal role involves working on innovative clinical development programs by analyzing and interpreting data critical to drug development. As part of a team that has supported over 94% of FDA-approved drugs, you will contribute to delivering high-quality clinical research solutions in a collaborative and rewarding environment.


Key Responsibilities:

  • Lead biostatistical activities on multiple clinical trials across various therapeutic areas.

  • Collaborate with cross-functional teams including Clinical, Medical Affairs, and Data Management.

  • Provide statistical consultation in the design, analysis, and reporting of clinical studies.

  • Ensure statistical integrity and accuracy of data interpretation in trial reports.

  • Develop and review statistical analysis plans and related documentation.

  • Stay compliant with regulatory standards such as ICH, FDA, and EMA guidelines.

  • Mentor and guide junior statisticians and ensure quality deliverables.


Required Skills & Qualifications:

  • Bachelor’s/Master’s/Ph.D. in Statistics, Biostatistics, or a related field.

  • Proven experience in clinical trials and biostatistical analysis (exact years of experience not specified).

  • Expertise in statistical software tools such as SAS, R, or equivalent.

  • In-depth understanding of clinical development processes and regulatory requirements (ICH-GCP, EMA, FDA).

  • Strong problem-solving, analytical, and organizational skills.

  • Excellent verbal and written communication abilities.

  • Ability to work independently and collaboratively in a matrix environment.


Perks & Benefits:

  • Competitive salary package (not disclosed; negotiable based on experience).

  • Comprehensive medical, dental, and vision insurance.

  • Career growth opportunities with global exposure.

  • Inclusive work culture focused on diversity and innovation.

  • Continuous learning and skill development programs.

  • Employee recognition and rewards platform.

  • Work with industry leaders in clinical research and drug development.


Company Description:

Syneos Health is a leading global biopharmaceutical solutions provider specializing in clinical development, medical affairs, and commercial solutions. Operating in over 110 countries with 29,000 employees, Syneos is committed to accelerating the delivery of life-changing therapies through its innovative clinical research model.


Work Mode:

On-site – Pune, Maharashtra, India


Call-to-Action:

Ready to make a meaningful impact in clinical research? Apply now to join Syneos Health as a Principal Biostatistician and help shape the future of biopharmaceutical innovation..