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