Statistical Programmer

Saama; India; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Saama is seeking a Statistical Programmer – L2 in India. You will independently handle mapping activities (SDTM/Client mappings) for simple to medium complexity data, using SAS with some Python/R if available.

You’ll ensure regulatory-compliant datasets and collaborate with Biostatistics and Data Management teams to deliver high-quality submissions. Graduation in Pharmacy or Computer Science with 2–4 years experience is expected.

Qualifications

• Understanding of clinical domain and mapping logic.
• Familiarity with SDTM/ADaM and submission packages.
• SAS programming experience up to 2 years; Python/R are a plus.

Responsibilities

• Handle mapping activities (SDTM/Client mappings) for simple to medium complexity.
• Import and export raw data and contribute to mapping specifications.
• Develop programs using SAS/R/Python to support clinical trial submissions.
• Identify data issues and report them to the appropriate team.
• Build CDISC/regulatory compliant datasets and check CRF annotations.
• Work with Biostatistics and Data Management teams and adhere to SOPs.
• Communicate with internal teams to create deliverables for pharmaceutical and CRO clients.

Skills

Clinical domain knowledge

CDISC standards

SAS programming

Python programming

R programming

Communication skills

Learning attitude

Education

Graduation in Pharmacy/Computer Science

2-4 years total experience

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 processesAssist 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.