Statistical Programmer

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.