Manage programming activities on project or study level, including managing CROs to ensure deliverables are accurate and compliant.
Act as a Programming SME for assigned studies, including authoring/reviewing programming specifications, such as SDTM/ADaM specifications, TFLs creation and QC for reporting events, eSUB packages, and documenting production and validation programs.
Work with Biostatistics and other functions for the development and maintenance of the data review and reporting tools, e.g., aCRF, SAP, and mock review, and any other statistical applications as appropriate.
Work with CRO counterpart on project timeline management; oversee and provide input on statistical programming activities, ensure timely and quality delivery.
Follow good programming practices, create, and validate global SAS macros and utilities to automate standard and frequent tasks, enhance quality and efficiency.
Apply programming skills to support statistical analysis, clinical reporting, regulatory submissions, Ad-Hoc/post-Hoc requests, and scientific publications.
Support the development of statistical programming SOPs and standard processes as needed.
Other duties as assigned.

A minimum of bachelor’s degree in a scientific, computer science or related field, training in statistics preferred.
A minimum of 5 years (8 years for principal) of statistical programming experience in a pharma, biotech, or CRO environment.
Knowledge of multiple phases of clinical development and experience in using SAS for clinical trials TFL report and integrated analysis for regulatory submissions is a must.
Hands-on experience and in-depth knowledge in CDISC standards, including SDTM and ADaM, controlled terminologies, aCRF, cSDRG, ADRG, and define xml.
Excellent knowledge of SAS/Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT; advanced SAS programming ability to implement standard statistical analyses; experience in developing SAS macros to standardize the workflow and internal processes.
Experience in CNS, pediatric rare disease area preferred.
Experience in CRO management.
Strong communication, leadership and interpersonal skills required.
An equivalent combination of education and experience may be considered.

Senior/Principal Statistical Programmer

Key skills