The statistical programmer will be responsible for supporting client’s clinical projects through the creation and maintenance of analysis data sets, CDISC related SAS programming and the execution of statistical analysis plans (SAPs) / abbreviated statistical analysis plans (aSAPs). S/he will accomplish this by producing and validating SAS programs for generating tables, listings, figures, other statistical outputs, and any CDISC related SAS programs, or data management related SAS programming or other non-SAS programming work assigned by project manager. Past CRO experience is required.
1. Convert raw SAS datasets to SDTM compliant SAS datasets.
2. Convert the SDTM compliant SAS datasets to the analysis-ready datasets (ADaM standards).
3. Generate Tables, Listings, and Figures as specified by the Statistical Analysis Plans.
4. Participate in reviewing SAPs / aSAPs, edit check specs, CRF annotation, database testing and implementation as required by the data management system.
5. Support the team by providing other programming or non-programming services as instructed by the supervisor.
Desired Skills and Experiences
1. Bachelor’s degree with a minimum of 5-8 years relevant professional clinical programming experience or experience in statistics/biostatistics, mathematics, computer science or other related fields, in addition to professional clinical programming experience; or a satisfactory combination of relevant experience and related levels of advanced formal education.
2. Familiarity with, and good understanding of, the basic concepts of Statistical Analysis Plans, Clinical Protocols, and CRFs.
3. Extensive knowledge and skills regarding SAS Base, SAS MACROS, SAS STATS, SAS graphs, and SAS ODS.
4. Good knowledge of CDISC standards and their implementation in the pharmaceutical environments.
5. Good knowledge and skills in generating Tables, Listings, and Figures using SAS compliant to FDA standards.
6. At least one of the other computer languages or statistical packages (R, S-plus, C++, Perl, Python, Java, etc.).
7. Experience as a SAS programmer in clinical research in the pharmaceutical industry, biopharma/biotechnology industry, or at a Contract Research Organization performing SAS programming responsibilities for multiple studies. Experience managing programming responsibilities for simultaneous Phase I, II and/or III clinical research studies is a plus.