Note: The job is a remote job and is open to candidates in USA. Clindata Insight Inc is seeking a Principal Biostatistician to lead biostatistics on Phase 2–3 clinical trials from protocol through regulatory submission. The role involves authoring and reviewing statistical analysis plans, providing statistical input for regulatory filings, and ensuring compliance with standards.

Responsibilities

• Lead biostatistics on Phase 2–3 clinical trials from protocol through regulatory submission
• Author and review SAPs: endpoints, analysis methods, and sample size calculations
• Lead or contribute to interim, DMC, and final analyses
• Provide statistical input to NDA/BLA filings, publications, and presentations
• Partner cross-functionally with clinical, programming, data management, and medical affairs
• Ensure CDISC-compliant, audit-ready statistical deliverables

Skills

• Lead biostatistics on Phase 2–3 clinical trials from protocol through regulatory submission
• Author and review SAPs: endpoints, analysis methods, and sample size calculations
• Lead or contribute to interim, DMC, and final analyses
• Provide statistical input to NDA/BLA filings, publications, and presentations
• Partner cross-functionally with clinical, programming, data management, and medical affairs
• Ensure CDISC-compliant, audit-ready statistical deliverables
• MS (7+ yrs) or PhD (4+ yrs) in Biostatistics or Statistics
• Hands-on SAS and/or R — independently develop, validate, and troubleshoot code
• Knowledge of FDA/EMA regulations, ICH guidelines, GCP, and CDISC standards
• Late-phase (Phase 2–3) clinical trial experience strongly preferred
• 2+ yrs cross-functional biostatistics leadership preferred

Benefits

• Health & dental · 401(k) match · Paid PTO
• Growth path: Senior → Principal → Senior Principal

Company Overview

• Clindata Insight is a biometrics consulting firm based in the San Francisco Bay Area specializing in biostatistics, statistical programming, CDISC implementation, big data for life science and talent solutions. It was founded in 2013, and is headquartered in Moraga, California, USA, with a workforce of 11-50 employees. Its website is https://www.clindatainsight.com.

Company H1B Sponsorship

• Clindata Insight Inc has a track record of offering H1B sponsorships, with 2 in 2023, 1 in 2022, 2 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.