Statistical Programmer

Saama-Technologies; Coimbatore District; On-site; INR 600,000 - 800,000; Full time

Job summary

Saama is hiring a Statistical Programmer – L2 in India to work on SDTM mappings for clients, applying SAS/R/Python skills to ensure regulatory-grade datasets. You will collaborate with cross-functional teams to deliver high-quality mapping outputs and data quality checks within a fast-paced environment.

The role requires 2-4 years of experience, familiarity with CDISC standards, and strong communication skills.

Qualifications

• Graduation in Pharmacy/Computer Science or equivalent.
• Total experience between 2-4 years.
• Knowledge of CDISC standards and clinical data mapping.

Responsibilities

• Handle mappings (SDTM/Client specific) of simple to medium complexity.
• Import and export raw data for mapping activities.
• Contribute to mapping specifications and SDTM datasets.
• Utilize SAS/R/Python for clinical trial submissions.
• Identify data issues and report them to the team.
• Ensure CDISC/regulatory compliant datasets are produced.
• Review CRF annotations for consistency with raw data.
• Debug SAS macros and custom functions as needed.
• Follow client processes and SOPs consistently.
• Assist senior team members with quality control and metrics.
• Collaborate with Biostatistics and Data Management teams.

Skills

Clinical Domain knowledge

CDISC Standards

SAS Programming

Python Programming

R Programming

Communication skills

Education

Graduation in Pharmacy/Computer Science

Tools

SAS

SDTM Mapping Tools

Job 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.

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.