Senior Statistical Programmer
Core
Senior Statistical Programmer creating derived analysis datasets and regulatory submission packages (TFLs) for clinical trials.
Role type
Senior IC statistical programmer
Builds
Derived analysis datasets, Tables/Figures/Listings (TFLs), and electronic submission packages (NDA, BLA, MAA) (via careerplan.io/jobs/R1604803-1-senior-statistical-programmer-at-bristolmyerssquibb)
Domain
Pharmaceutical clinical development and regulatory submissions
Required skills
SAS programming, CDISC standards (SDTM, ADaM), relational databases, upstream data handling (eDC, workflow), downstream outputs (ADaM, DDT), XML, Pinnacle 21, regulatory standards, clinical trial methodology
Preferred skills
Global regulatory filing experience (NDA, BLA, MAA), end-to-end drug development knowledge, R programming, Linux
Technologies
SAS, XML, Pinnacle 21, MS Office, Linux, R
Responsibilities
Write and validate SAS programs for TFLs, contribute to electronic submission preparation, review Statistical Analysis Plans (SAPs), partner with vendors on programming standards, lead programming assignments across multiple projects, improve team efficiency
Seniority
Senior, hands-on IC