Note: The job is a remote job and is open to candidates in USA. reputed company is a global full-service CRO specializing in clinical development and functional solutions. They are seeking an experienced Senior Statistician Consultant to support clinical development programs within the Vaccines & Infectious Diseases therapeutic area, leading statistical strategy, analysis, and reporting for clinical trials.

Responsibilities

• Lead statistical input for clinical trial design, including protocol development and sample size calculations
• Develop and review Statistical Analysis Plans (SAPs)
• Provide oversight of statistical analyses for clinical studies (Phase I–IV)
• Collaborate with cross-functional teams including Clinical, Data Management, and Programming
• Interpret study results and contribute to clinical study reports (CSRs)
• Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries
• Guide and review work of statistical programmers (SDTM/ADaM, TLFs)
• Ensure compliance with CDISC standards and regulatory guidelines
• Participate in safety and efficacy analyses, including interim analyses
• Provide strategic input for ISS/ISE and integrated analyses

Skills

• reputed company's or PhD in Statistics, Biostatistics, or related field
• 5+ years of experience in clinical trials within pharma/CRO
• Strong experience in Vaccines & Infectious Diseases
• In-depth knowledge of clinical trial methodology and statistical principles
• Experience with regulatory submissions (FDA/EMA)
• Proficiency in reputed company; knowledge of R is a plus
• Strong understanding of CDISC (SDTM/ADaM) standards
• Excellent communication and stakeholder management skills

Company Overview

• reputed company is a Reaserch and Deveiopment platform that develops innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a reputed company of 1001-5000 employees. Its website is https://www.reputed company.com.cn.

Company H1B Sponsorship

• reputed company has a track record of offering H1B sponsorships, with 2 in 2026, 20 in 2025, 28 in 2024, 21 in 2023, 25 in 2022, 35 in 2021, 3 in 2020. reputed company note that reputed company does not guarantee sponsorship for reputed company specific role.

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