Clinical Research Statistician

15 hours ago

Bengaluru, Karnataka, India beBeeStatistical Full time ₹ 15,00,000 - ₹ 20,00,000
Statistical Programmer Role

We are seeking a skilled Statistical Programmer to contribute to meaningful clinical research while developing expertise in regulatory compliance and industry best practices. As a key member of our team, you will be responsible for programming, validating, and delivering statistical outputs for clinical trials. Your primary objective will be to ensure compliance with regulatory standards and industry best practices.

Responsibilities

- Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting. This includes creating and maintaining analysis datasets following CDISC implementation guidelines, as well as performing data validation and quality control checks to ensure data accuracy.

- Map clinical trial data to CDISC standards (SDTM and ADaM) ensuring compliance with regulatory requirements. You will also generate and maintain CDISC documentation including define.xml files, reviewer's guides, and annotated case report forms (aCRF).

- Conduct Pinnacle21 validation checks and resolve any compliance issues. Additionally, you will ensure all deliverables meet regulatory submission standards (FDA, EMA, etc.).

Requirements

- Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field. An advanced degree is preferred but not required with relevant experience.

- Minimum 3+ years of experience as a statistical programmer in clinical research or pharmaceutical industry. Advanced SAS programming skills with expertise in Base SAS, SAS/STAT, SAS/GRAPH, and SAS Macro language are essential. A strong understanding of clinical trials including study designs, endpoints, and regulatory requirements is also necessary. Proven experience with CDISC standards (SDTM and ADaM) and data mapping techniques, as well as hands-on experience with Pinnacle21 validation software and resolving compliance issues, are highly desirable.

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