Quick Overview
Seniority
Mid Senior
Work mode
Hybrid
Location
United States
Posted
Yesterday
Clinical TrialsComplianceGoogle CloudRegulatory Compliance
Job Description
No h1b
-biggest things to look for is Phase I an PK/PD experience. for Phase I studies, First in Human (FIH), Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD) / dose escalation.
Senior Biostatistician
Ulta Sciences
Remote
12 month contract with possible extension
Primary Responsibilities:
- The Senior Biostatistician leads statistical strategy and execution across clinical trials, ensuring robust design, analysis, and interpretation aligned with regulatory standards.
- This role partners cross functionally with Clinical, Data Management, and Regulatory teams to drive data-driven decision making and submission readiness.
Role description:
- Design and review statistical analysis plans (SAPs), protocols, and CRFs for Phase I–IV trials
- Perform and oversee statistical analyses using SAS/R, ensuring reproducibility and regulatory compliance
- Lead development of CDISC-compliant datasets (SDTM, ADaM) and TLFs for CSR and regulatory submissions
- Collaborate with cross-functional teams to define endpoints, estimands, and interim analysis strategies
- Provide statistical input for regulatory interactions (e.g., FDA, EMA) and advisory board meetings
- Mentor junior biostatisticians and contribute to SOP development and process optimization
Qualifications:
- PhD or Master’s in Biostatistics, Statistics, or related field skill: 3+ years of experience in clinical trial statistics, preferably in pharma or CRO
- Proficiency in SAS and R; experience with CDISC standards and regulatory submissions
- Strong understanding of ICH-Google Cloud Platform, FDA/EMA guidelines, and statistical methodologies
- Excellent communication and leadership skills
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