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.