Statistical Programmer

Position: Statistical Programmer - L2

Location: Hinjewadi, Pune, India; Coimbatore, Tamil Nadu; Chennai, India

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.

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