The Biostatistical Programmer will work collaboratively with team members to develop workflows and SOPs that are aligned with industry standards as well as conduct the necessary activities to execute a clinical trial.
? Program mapped and analysis datasets per CDISC standards, tables, listings, and figures and other programming activities in a timely manner
? Perform quality control review of programming activities to ensure that outputs meet quality standards and project requirements
? Create and maintain statistical programming project documentation, including: project documentation, testing, and verification/quality control documents and programs
? Negotiate and establish accurate time estimates for completion of study programming activities with internal team members and Biostatistical Management
? Direct the programming activities of other programming personnel and monitor progress on programming deliverables
? Assist in developing programming SOPs/Workflows
? Be knowledgeable of industry regulations
? Program efficiently and accurately in SAS
? Act as resource for SAS programming within organization
? Participates in a highly collaborative environment as an integral member of a clinical project team to create data displays and data summaries for studies
? Serves as a supporting programmer on multiple projects
? Ability to collaborate effectively with nonstatisticians and project managers, to work independently with minimal guidance, and as part of a team
? Effective oral and written communication and interpersonal skills
Qualifications
The right candidate will have CDISC, STDM, and ADaM experience. Also, will have worked for a CRO
? Bachelor’s degree in Biology, Biotechnology, Mathematics, Statistics, Computer Science, or a related field plus 2 years of experience as BioStatistical/Analysis Programmer or related role
? Proficient knowledge of SAS/BASE, SAS/SQL, SAS/STAT, SAS GRAPH, and SAS Macro Language
? Programming or producing analysis datasets, summary tables, data listings and graphical representations of clinical trials data at a Pharmaceutical company or Contract Research Organization (CRO);
? Using clinical regulatory guidelines (FDA/CFR, ICH/GCP, CDISC) in programming decisions
? Statistical programming or reports in Phase IIII clinical trials utilizing SAS Programming (SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL);
? Application of CDISC guidelines mapping data to SDTM and ADaM formats required