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Experienced Biostatistician (Based In Pune)

0-2 years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: PhD 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

Employer: Medpace
Industry: Clinical Research (CRO)
Department: Biostatistics
Employment Type: Full-Time
Location: Pune, India

Job Summary:

Medpace is seeking a full-time Biostatistician to join its Biometrics team in Pune. This role involves statistical analysis, clinical trial planning, and regulatory compliance. Candidates will contribute to clinical development plans, data analysis, and statistical reporting.

Responsibilities:

  • Support clinical development planning by reviewing study protocols and preparing statistical methodologies.
  • Develop Medpace Data Analysis Plans for assigned projects.
  • Program and analyze study data, ensuring statistical accuracy.
  • Review study results and contribute to clinical/statistical reports.
  • Collaborate with teams for CRF design, database setup, and data validation.
  • Interpret and communicate statistical findings to medical writing teams.

Qualifications:

  • Ph.D. in Biostatistics/Statistics with pharmaceutical clinical trial experience.
  • Strong experience in SAS® programming or equivalent statistical software.
  • In-depth knowledge of advanced statistical methods and regulatory guidelines for drug development.
  • Familiarity with Phase I-IV clinical trials and statistical methodologies.
  • Experience with ISS, ISE, and electronic submissions.
  • Excellent verbal and written communication skills.

Why Join Medpace?

  • Hybrid work-from-home options (depending on role and level).
  • Competitive PTO packages & flexible work schedules.
  • Employee appreciation events & wellness initiatives.
  • Structured career paths with growth opportunities.
  • Recognized as one of America’s Most Successful Midsize Companies (2021-2024) by Forbes.

About Medpace:

Medpace is a full-service clinical contract research organization (CRO), providing Phase I-IV clinical development services to biotech, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace employs 5,000+ professionals in 40+ countries.