Responsibilities. Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users. Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design. Use study protocol, CRF, Data Transfer Agreements from vendors, ...
Responsibilities. 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. Apply programming skills to support statistical ana...
Greetings from IT Engagements. Position: Clinical SAS Programmer. Location: Pleasanton, CA Onsite. Skills. Must have knowledge of Base SAS, SAS/STAT, SAS macros, and SAS/GRAPH. Experience in TLFs, Submissions etc. Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field. Minimum of 8 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer. Knowledge of SAS, SAS Macros, SAS/STAT,...
Responsibilities. Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users. Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design. Use study protocol, CRF, Data Transfer Agreements from vendors, ...
Responsibilities. . Develop, validate, and maintain SAS programs for clinical data analysis, reporting, and submission in adherence to CDISC standards, regulatory guidelines, and company SOPs. . Lead the programming activities for regulatory submissions, ensuring timely and accurate delivery of high-quality datasets, tables, listings, and figures (TLFs). . Collaborate closely with biostatisticians to generate analysis datasets, perform statistica...
Responsibilities. . Performing data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy (ISS/Client), utilizing SAS programming. . Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs). . Develop SAS programs and generate complete, accurate and validated statistical TLGs in well-defined formats. . Program SDTM and ADaM datasets according to the dataset specific...
Responsibilities. . . Minimum 1-2 years in Pharmaceutical/Biotechnology industry or equivalent statistical programming and IT consulting role. . Familiarity with industry wide standards such as CDISC and HL7. . Excellent knowledge of various modules of SAS including but not limited to SAS/STAT, SAS/Graph. Understanding and experience with SAS/Connect, SAS/Access. Experience of working with various versions of SAS including SAS-8.2, and SAS-9. . E...
