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Experienced Biostatistician (Based In Pune)

10+ years
Not Disclosed
10 June 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

 

Experienced Biostatistician at Medpace – Pune (On-site)

Job Summary

Medpace, a global clinical research organization, is hiring an Experienced Biostatistician for its Pune location. This full-time role requires over 10 years of clinical trial statistical experience and strong expertise in SAS® programming. As part of the Biometrics team, you will contribute to key statistical aspects of clinical development, from trial planning to final reporting, helping to drive global drug development success.


Key Responsibilities

  • Participate in the preparation of clinical development plans.

  • Review study protocols and contribute to the development of statistical methodologies.

  • Design and implement detailed Data Analysis Plans (DAP) for assigned projects.

  • Perform SAS® programming for study analysis, review study results, and write statistical sections for clinical/statistical reports.

  • Collaborate with data management teams on CRF design, database setup, and data cleaning to ensure data suitability for statistical analysis.

  • Communicate statistical results clearly to medical writing teams to ensure accurate report interpretation.


Required Skills & Qualifications

  • Ph.D. in Biostatistics/Statistics with substantial experience in pharmaceutical clinical trials.

  • Minimum 10+ years’ industry experience in clinical trials or related fields.

  • Strong expertise in SAS® programming (or equivalent tools).

  • Familiarity with advanced statistical methods and other statistical software.

  • Sound understanding of regulatory guidelines (FDA, EMA) for drug development.

  • Experience with complex statistical methods for Phase I-IV clinical trials.

  • Proficiency in generating analysis databases and performing analyses for complex projects including ISS, ISE, and e-submissions.

  • Excellent verbal and written communication skills.


Perks & Benefits

  • Flexible work environment.

  • Competitive salary and benefits package.

  • Generous PTO (Paid Time Off) plans.

  • Structured career growth opportunities.

  • Company-sponsored appreciation events and wellness initiatives.

  • Opportunity to work with a globally recognized award-winning CRO.


Company Description

Medpace is a leading global Clinical Research Organization (CRO) offering Phase I-IV clinical development services to pharmaceutical, biotechnology, and medical device industries. With expertise across oncology, cardiology, metabolic diseases, and more, Medpace accelerates drug development through scientific excellence and global reach.


Work Mode

On-site (Pune, India)


Call-to-Action

Ready to advance your career with a global leader in clinical research? Apply now to become part of Medpace’s Biometrics team and impact the future of drug development.