Job Title: Principal Biostatistician
Location: Flexible/Remote (Sponsor-Dedicated)
Category: Biostatistics
Business Unit: Flexible Solutions
Company: Fortrea
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.
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
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
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
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)
Gujarat :
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Siliguri |Illinois :
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