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Experienced Biostatistician (Based In Pune)

10+ years
Not Disclosed
10 Nov. 21, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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 (Pune, India)

Location: Pune, India
Department: Biostatistics
Job ID: 11159
Category: Biostatistics / Clinical Research


Job Overview

Medpace is seeking an Experienced Biostatistician to join its Biometrics team in Pune. This full-time position plays a key role in supporting global clinical development activities. The ideal candidate will possess deep expertise in statistical methodologies, clinical data analysis, and regulatory-compliant biostatistical practices. This role offers significant opportunities for career growth within a global clinical research organization.


Key Responsibilities

  • Contribute to the development of comprehensive clinical development plans.

  • Review study protocols and develop detailed statistical methodologies.

  • Create and maintain Medpace Data Analysis Plans for assigned clinical projects.

  • Program and validate statistical analyses, interpret study outcomes, and prepare relevant statistical report sections.

  • Collaborate closely with clinical data teams to ensure CRF design, database structure, and data cleaning support accurate analysis of key study variables.

  • Communicate statistical findings to medical writing teams to ensure precise interpretation in clinical and regulatory documents.


Required Qualifications

  • Ph.D. in Biostatistics or Statistics with relevant clinical trial experience.

  • Minimum 10 years of industry experience in clinical trials or equivalent biostatistical roles.

  • Strong proficiency in SAS programming or equivalent statistical software.

  • Knowledge of advanced statistical methods and industry-standard tools used in Phase I–IV clinical trials.

  • Thorough understanding of regulatory requirements and global guidelines for drug development.

  • Hands-on experience generating analysis datasets and conducting analyses for medium to highly complex studies, including ISS, ISE, and electronic submissions.

  • Excellent written and verbal communication skills.


About Medpace

Medpace is a leading full-service Clinical Research Organization (CRO) providing Phase I–IV development services for pharmaceutical, biotechnology, and medical device companies. With more than 5,000 employees across 40+ countries, Medpace applies scientific rigor and disciplined processes to accelerate development of safe and effective therapeutics across key therapeutic areas including oncology, cardiology, CNS, metabolic disorders, endocrinology, antiviral, and anti-infective research.


Why Join Medpace?

  • Flexible and supportive work environment

  • Competitive compensation structure

  • Comprehensive benefits and paid time off (PTO)

  • Clear career progression pathways

  • Employee recognition initiatives and wellness programs

  • Global exposure and collaborative work culture

  • Multiple industry awards, including Forbes recognition as one of America’s Most Successful Midsize Companies (2021–2024) and recurring CRO Leadership Awards


Next Steps

Qualified applicants will be reviewed by the Medpace recruitment team. If your profile aligns with the role, you will be contacted with further details regarding the next steps in the selection process.