Biometrics/biostatistics, Computer systems analysis/Programming, Mathematical statistics
The Senior Statistical Programmer creates statistical analysis outputs (tables, figures and listing) to be used in support of clinical study reports, abstracts, posters, manuscripts, and other clinical publications; support systems to produce electronic regulatory submissions.
The incumbent designs and writes program specifications based on consultations with Programming and Biostatistician staff. Revises programs for corrections, enhancements, or system environment changes
The Programmer assists in establishing standardized programming code and processes utilizing CDISC standards and the current technologies.
Develop SAS programs for SDTM and ADaM, datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, and pooled analysis for clinical studies and submission activities.
Works directly with biostatisticians and other programmers to achieve milestones for the assigned project.
Manages creation, review, completion and delivery of assigned statistical programming activities.
Performs validation per the departmental SOP to ensure that outputs meet quality standards and project requirements. Works with Programmer, Biostatistician, and other project team members to resolve discrepancies or any findings.
Actively provide feedback to Clinical Data Management on case report form (CRF) design, data management plan, and edit specifications
Provides programming support to Clinical Data Management
Applies CDISC knowledge (SDTM and ADaM) standards to dataset programming.
Master’s or equivalent degree in Biostatistics, Statistics, Epidemiology, Mathematics, Computer Science, Life Sciences or related field.
3+ years of pharmaceutical experience.
Good technical skills with SAS STAT, SAS GRAPH and SAS MACRO.
Experience in high-level efficient SAS programming.
Working knowledge of CDISC-compliant SAS data structures and other related regulatory guidance.
Excellent interpersonal, communication, problem solving, and analytical skills.