Statistical Programmer

2 Months ago • 2-4 Years • Programming

Job Summary

Job Description

The Statistical Programmer, L2, will report to the Principal Statistical Programmer. They are responsible for independently working on the mapping activities (SDTM/Client specific mappings), including understanding clinical domains, mapping logic, and data issues. They will utilize SAS/R programming/Python programming skills for clinical trial study submissions. They will also develop programs to identify data issues, utilize guidelines to build CDISC/regulatory compliant datasets, and communicate with internal and external teams to create deliverables. They will also work with Biostatistics and Data Management members on clinical projects.
Must have:
  • Clinical Domain knowledge
  • Familiarity with CDISC Standards (SDTM Knowledge)
  • SAS Programming (Experience up to 2 years)
  • Good Communication skills
Good to have:
  • Python Programming will be an added advantage
  • R Programming will be an added advantage

Job Details

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.

About US: Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), Generative AI and advanced-analytics, accelerating your time to market. We offer AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com.

 

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