Statistical Programmer reports to Principal Statistical programmer 3/Lead, Statistical Programming (L4 (3) or M1), is responsible to work independently on the most of the Mapping activities (SDTM/Client specific mappings) which are simple and medium complex for assigned client in the given environment for the standard domains. Understanding clinical domain, mapping logic, data issues is a part of this role. Learning the product/system/mechanism to be used for SDTM mapping is a part of this role.
●Clinical Domain knowledge
●Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package)
●SAS Programming (Experience up to 2 years)
●Python Programming will be an added advantage
●R Programming will be an added advantage
●Good Communication skills, learning attitude and good team player
●Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute.
●Total experience is between 2 - 4 years
●Ability to pick up multiple tools/technologies on the job.
●Import and Export raw data
●Contribute to Mapping specifications
●Utilize SAS/R programming/Python programming skills for clinical trial study submissions
●Develop programs identifying data issues and reporting them to the appropriate team
●Utilize appropriate guidelines to build CDISC/regulatory compliant datasets
●Understand CRF annotations and check for consistency with raw data
●Ability to debug custom functions/SAS Macros and fix issues
●Good understanding of clinical data and domain
●Follow Client Processes and SOPs
●Assist senior team members in quality control processes
●Assist senior team members with team metrics
●Communicate with an internal team to create deliverables for pharmaceutical and CRO clients
●Work in tandem with Biostatistics and Data Management members on clinical projects
●Communicate with programming and statistics leads
●Make sure you are compliant with company policies/SOPs.
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Saama develops life science solutions that accelerate the delivery of therapies to patients. With innovative AI technologies, Saama drives breakthrough intelligence into clinical and commercial operations. The Saama platform powered the clinical trial that led to the world’s first COVID-19 vaccine. Headquartered in Campbell, CA, with employees around the globe, Saama is committed to helping customers save and improve lives. Discover more at saama.com.
