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Biostatistician Ii

0-2 years
Not Disclosed
10 Nov. 11, 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

Biostatistician II – Structured Job Description

Location: Bangalore
Category: Clinical
Job ID: 252245


🔹 Summary of Responsibilities

1. Statistical Leadership (Simple Studies)

  • Serve as Lead Biostatistician on simple clinical studies.

  • Provide statistical oversight and actively participate in project meetings.

  • Communicate project status, tasks, and budget awareness to line managers and project managers.

2. Statistical Planning

  • Prepare Statistical Analysis Plans (SAPs), including:

    • Mock Table, Figure, Listing (TFL) shells

    • For simple and medium-complexity studies

  • Work under supervision of senior biostatisticians.

3. Statistical Analysis

  • Perform statistical analyses for medium-complexity clinical studies.

  • Conduct detailed statistical review of TFLs before client delivery.

4. Study Documentation & Review

  • Review:

    • Case Report Forms (CRFs)

    • Study-specific plans and specifications

  • Contribute statistical input to Clinical Study Reports (CSR) for simple studies.

5. Randomization & Sample Size

  • Generate and review randomization schedules under senior supervision.

  • Perform sample size calculations (primarily for Clinical Pharmacology studies) under guidance.

6. Additional Activities

  • Perform all other assigned statistical or documentation tasks as required.


Minimum Qualifications

  • Master’s degree (or equivalent) in Biostatistics or related field.


Required Experience (3–5 Years)

  • 3–5 years of relevant experience or equivalent combination of education and experience.

  • Ability to program in at least one statistical software package (SAS® preferred).

  • Strong communication skills for explaining statistical concepts.


Preferred Qualifications

  • Bachelor’s degree (in addition to the required Master’s, or as an alternative where relevant).


Work Environment

  • Travel required (extent not specified).

  • Standard office or remote setup depending on project needs.