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Principal Biostatistician

0-2 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Part Time Remote 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 Title: Principal Biostatistician
Location: Flexible/Remote (Sponsor-Dedicated)
Category: Biostatistics
Business Unit: Flexible Solutions
Company: Fortrea 


Job Description:

As an experienced Principal Biostatistician in Fortrea’s sponsor-dedicated Flexible Solutions business unit, you play a key role in the successful delivery of complex clinical trials for leading global pharmaceutical and biotech clients. Your responsibilities will include developing and reviewing Statistical Analysis Plans (SAPs) and providing programming support to global, multidisciplinary project teams.


About the Team:

  • Long-standing 10-year partnership with one of Fortrea’s top sponsors

  • Team of over 150 global colleagues across US, EU, and APAC regions

  • Strong culture of collaboration, support, and knowledge sharing


What Fortrea Offers:

  • Meaningful work with a respected, global company

  • Competitive compensation and local benefits (pension, health plans, remote work allowances)

  • Work-life balance and flexible working hours

  • Comprehensive onboarding and a personal mentor

  • Training and career development support

  • Support from Line Manager, global team, and 19,000+ colleagues worldwide


Key Responsibilities:

  • Lead complex studies including NDAs and multi-protocol programs

  • Provide statistical oversight and attend project meetings

  • Perform project management: resource planning, timeline, and milestone tracking

  • Serve as DMC Support Statistician, develop DMC charters, attend meetings

  • Create/review Statistical Analysis Plans (SAPs)

  • Conduct statistical reviews of TFLs (Tables, Figures, Listings)

  • Review CRFs and study specifications

  • Develop statistical protocol sections under statistical consultant supervision

  • Prepare and review randomization specs and schedules

  • Mentor and train junior staff; oversee their deliverables

  • Present knowledge internally and externally (seminars, conferences)

  • Represent department in bid defense meetings and audits

  • Act as Subject Matter Expert (SME); contribute to SOPs and initiatives


Required Qualifications:

  • Degree in Statistics, Computer Science, or related field

  • Solid experience as a Lead Biostatistician in CRO, pharma, or biotech

  • Proficiency in SAS® and a range of statistical procedures (e.g., non-parametric, linear/non-linear models, categorical/survival analysis)

  • Experience with SDTM, ADaM, and TFLs

  • Effective communicator of complex statistical concepts

  • Strong understanding of the clinical trial process

  • Skilled in SAP creation, statistical analysis, and reporting

  • Excellent organizational and attention-to-detail skills

  • Business fluency in English (verbal and written)