Biostatistical Programming Senior Associate
Core
Provide hands-on statistical expertise to clinical studies across the drug development lifecycle, authoring statistical documents and performing data analyses.
Role type
Senior Associate Biostatistical Programmer
Builds
Statistical Analysis Plans (SAPs), Table/Figure/Listing (TFL) shells, submission data files (SDTM/ADaM), and clinical study reports.
Domain
Biotechnology / Clinical Trials
Required skills
Statistical programming (SAS or R), Clinical trial methodology, CDISC standards (SDTM/ADaM), Statistical analysis (primary/secondary endpoints), Regulatory compliance documentation
Preferred skills
Leadership of studies/projects, Protocol authoring, CSR review, AI/automation tools, Drug development lifecycle knowledge
Technologies
SAS, R, CDISC
Responsibilities
Author and review statistical documents (SAPs, TFL shells, SDTM/ADaM specs), Conduct and document statistical analyses for clinical trials, Perform quality control (QC) of datasets and outputs, Participate in Clinical Study Team (CST) meetings, Collaborate with programming colleagues, Contribute to clinical publications and regulatory submissions, Review deliverables from external suppliers
Seniority
Senior, hands-on IC