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About the role
Key responsibilities & impact- Lead statistical strategy and delivery for complex studies and programs (including submissions and multi-protocol work)
- Develop and review Statistical Analysis Plans and ensure quality of statistical outputs
- Provide oversight of statistical analyses, Tables, Figures & Listings (TFLs), and study reporting
- Collaborate closely with cross-functional teams and act as a key statistical advisor
- Support regulatory interactions, publications, and post hoc analyses
- Contribute to study design, protocols, and randomization planning
- Mentor junior statisticians and provide technical leadership
- Represent Biostatistics in client interactions, bid defenses, and audits
Requirements
What you’ll need- Advanced degree (MSc/PhD) in Statistics, Biostatistics, or related field
- Significant experience as a Lead/Principal Biostatistician in CRO, biotech, or pharma
- Strong knowledge of statistical methods for clinical trials and regulatory requirements (FDA/EMA)
- Proficiency in SAS (including advanced procedures)
- Solid experience with CDISC standards (SDTM, ADaM, TFLs)
- Ability to communicate complex statistical concepts to diverse stakeholders
- Strong organizational skills, attention to detail, and collaborative mindset
- Fluent in English
Benefits
Comp & perks- Competitive compensation and comprehensive benefits
- Flexible, remote-friendly working environment
- Strong career development and growth opportunities
- Supportive, collaborative team culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysisstatistical analysis plansstatistical methodsSASCDISC standardsSDTMADaMTables, Figures & Listingsstudy designrandomization planning
Soft Skills
communicationorganizational skillsattention to detailcollaborative mindsetmentoringtechnical leadership
Certifications
MScPhD
