Statistical Programmer

Description

Statistical Programmer – L2

Job Summary:

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.

Knowledge, Skills & Abilities:

●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

Education and Work Experience:

●Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute.

●Total experience is between 2 - 4 years

Responsibilities:

●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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