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AD, Statistical Programming
3 months ago
Ad, Statistical Programming - Permanent - Menlo Park, California
Proclinical is seeking a Statistical Programmer with a strong background in SAS programming and CDISC standards.
Primary Responsibilities:
The ideal candidate will be responsible for reviewing and validating data, developing SAS programs for data analysis and ensuring the timely delivery of analysis results. This role also involves staying updated with regulatory requirements and participating in standards governance.
Skills & Requirements:
Extensive knowledge of SAS BASE, MACRO, STAT, GRAPH, and ACCESS.In-depth understanding of CDISC SDTM and ADaM specifications and related regulatory guidance.Proficiency with Pinnacle 21 and addressing errors and warnings to produce acceptable reviewer's guides.Familiarity with data visualization tools (e.g., Spotfire, Tableau, RShiny) is a plus.Ability to work independently in unstructured situations.Capability to communicate technical information to a non-technical audience.Sc./B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or a related field (M.S. preferred).Experience in managing the delivery of statistical programming projects by CROs.Problem-solving skills. The Ad, Statistical Programmer's responsibilities will be:Collaborate with Data Management to review CRO-generated CRFs, database specifications, and data transfer specifications.Develop specifications and execute SAS programs for study data analysis and clinical study report preparation.Create SAS macros and tools for repeated use in exploratory and post-hoc analyses.Review and provide feedback on CRO-generated SAPs and SDTM and ADaM specifications.Validate data and statistical analysis results generated by CROs.Stay updated with regulatory requirements on CDISC and clinical regulatory programming standards.Assess CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness.Participate in standards governance and develop biometric department operational processes. If you are having difficulty in applying or if you have any questions, please contact Jennifer Iantosca at (+1) orProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
