Statistical Programmer

3 weeks ago

Bangalore, India Trigent Software Inc Full time

Title: Statistical Programmer

Location: Remote

Duration: Full-time

Responsibilities:

• Develop and maintain programs using R to generate Tables, Listings, and Figures (TLFs) as part of clinical trial reporting.

• Implement CDISC standards (SDTM, ADaM) for clinical data submission and reporting.

• Manage clinical datasets and ensure data integrity, quality, and compliance with industry standards.

• Validate datasets, perform quality checks, and troubleshoot issues to ensure accurate reporting.

• Work closely with clinical data managers, statisticians, and project managers to understand data requirements.

• Provide programming support for regulatory submissions and ad-hoc analysis requests.

• Develop automated processes to streamline workflows and improve reporting efficiency.

• Stay updated with advancements in R programming and clinical data standards.

• Prepare detailed documentation, including specifications and programming guidelines, to meet regulatory and compliance standards.

• Ensure all programming activities align with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).

• Prepare regular progress reports and communicate project updates effectively to stakeholders.

• Address programming challenges and propose innovative solutions for data management.

Qualifications:

• Proficiency in R programming, with hands-on experience in CDISC standards (SDTM, ADaM) and TLFs generation.

• Strong problem-solving skills, attention to detail, and the ability to work independently in a remote environment

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