Master's in Statistics, Biostatistics, or related field with 5+ years experience in clinical study design and analysis.
PhD in a related field with 3+ years experience may also be considered.
Proficient in SAS programming, particularly in statistical procedures for clinical data analysis.
Extensive experience with CDISC and FDA standards for SDTM and ADaM dataset creation.
Responsibilities
Support Phase 2 and 3 clinical studies with hands-on data checking and programming.
Conduct statistical analysis deliverables under guidance.
Collaborate with cross-functional teams to ensure data integrity and compliance.
Assist in the design and implementation of analysis plans for clinical trials.
Provide mentorship on biostatistical methods and tools to junior staff.
Full Job Description
Summary:
The senior/principal biostatisticians will be supporting Phase 2 or 3 studies and be hands-on with data checking, programming, and statistical analysis deliverables under guidance.
Qualifications:
Master's in Statistics, Biostatistics, or related field with 5+ years of experience in the design, analysis, and reporting of clinical studies.
OR
PhD in a related field with 3+ years of experience
Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.
