About the Role
Provide statistical expertise in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial documents.
Support SAP writing, data analysis, and ensure accuracy of statistical outputs.
Provide statistical advice for regulatory submissions (NDA/BLA) to FDA, EMEA, or other agencies.
Apply statistical methodology across multiple therapeutic areas and trial phases (I–IV).
Perform statistical analyses and generate TFLs to present results.
Requirements
Ph.D. or M.S. in Statistics, Biostatistics, Life Sciences, or related field.
0–1 year of experience in clinical trials or regulatory submissions in pharmaceutical, biotech, or CRO settings.
Strong SAS programming and statistical analysis skills.
Solid knowledge of clinical study design and CDISC standards (SDTM & ADaM).
About the Company