Statistical Programmer
Core
Leads statistical programming activities for clinical trials, developing SAS programs for ADaM datasets, tables, listings, and figures to support regulatory submissions.
Role type
Senior/Lead Statistical Programmer (Clinical Data Management)
Builds
CDISC-compliant ADaM datasets, TLFs (Tables, Listings, Figures), and regulatory submission packages
Domain
Clinical Research / Biopharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS Programming (Base, Macros, SQL), CDISC Standards (SDTM, ADaM, TLFs), Pinnacle21, Define.xml, Regulatory Submission Knowledge (FDA/PMDA/EMA), Team Leadership, Resource Planning
Preferred skills
Therapeutic expertise in Oncology, Immunology, Neuroscience, Phase I–IV trial experience, Onshore-offshore collaboration
Technologies
SAS, Pinnacle21, SQL
Responsibilities
Leads statistical programming activities for a compound/indication, Leads a team of statistical programmers and manages resource planning, Develops and oversees SAS programs for ADaM data sets, Develops and oversees SAS programs for TLFs, Ensures consistency of ADaM data sets
Seniority
Senior/Lead, hands-on IC with team management
