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Biostatistician Ii

3-5 years
Not Disclosed
10 June 11, 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

Fortrea is seeking a skilled Biostatistician II for its Bangalore location to contribute statistical expertise across a range of clinical research studies. The role offers opportunities to develop and execute statistical analysis plans, conduct data reviews, and support clinical trial documentation processes. Ideal for professionals with 3–5 years of experience in biostatistics, especially in the healthcare and pharmaceutical research sectors.


Key Responsibilities

  • Serve as Lead Biostatistician on simple studies, overseeing statistical analysis and participating in project meetings.

  • Develop Statistical Analysis Plans (SAP), including mock Tables, Figures, and Listings (TFLs) for studies of simple to medium complexity.

  • Perform statistical analyses and ensure the overall quality review of TFL outputs prior to client delivery.

  • Review Case Report Forms (CRFs) and study-specific documentation for accuracy and completeness.

  • Generate and review randomization schedules based on specifications provided, under senior supervision.

  • Perform sample size calculations for Clinical Pharmacology studies as guided by senior staff.

  • Offer statistical inputs and reviews for Clinical Study Reports (CSR).

  • Maintain communication with line management and project managers regarding task progress and budget considerations.


Required Skills & Qualifications

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

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

  • Proficiency in statistical software (SAS® preferred).

  • Strong ability to explain statistical methods and results to non-statistical stakeholders.

  • Knowledge of clinical research processes, statistical documentation, and regulatory requirements.

Preferred:

  • Bachelor’s degree holders with exceptional experience will also be considered.


Perks & Benefits

  • Exposure to global clinical trial projects.

  • Opportunity to work with industry leaders in pharmaceutical research.

  • Flexible travel options as per project demands.

  • Continuous learning and career advancement in the CRO industry.


Company Description

Fortrea is a top global Contract Research Organization (CRO) delivering advanced clinical development and technology solutions across 20+ therapeutic areas. With operations in over 100 countries, Fortrea partners with pharmaceutical, biotech, and medical device companies to transform healthcare worldwide.


Work Mode

On-site (Bangalore)


Call-to-Action

If you are passionate about applying statistical rigor to clinical trials and driving breakthrough therapies, apply now to join Fortrea’s dynamic global team.