SDTM Programmer

PRI INDIA IT SERVICES PRIVATE LIMITED; Bengaluru; Presencial; INR 1 200 000 - 1 800 000; Tempo integral

Resumo da oferta

PRI INDIA IT SERVICES PRIVATE LIMITED seeks an experienced SAS Programmer to develop, validate, and maintain SDTM datasets in line with CDISC standards for clinical study data. The role involves independent validation, QC, and support for regulatory submissions.

You will interpret study protocols, CRFs, and data mappings, ensuring data integrity and timely delivery. Collaboration with vendors and internal teams across phases will be essential, with emphasis on quality and standardization.

Qualificações

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field.
• 7+ years of clinical/statistical programming experience in pharma/biotech/CRO.
• Strong SAS programming skills with clinical trial data processing and reporting experience.
• Hands-on SDTM implementation, mapping, validation, and submission readiness.
• Understanding of clinical trial data structures, databases, and data management processes.
• Experience handling source data from EDC and external vendors to SDTM datasets.
• Knowledge of SDTM metadata, mapping specifications, define.xml generation, and data quality checks.
• Experience with Pinnacle 21, XML, and MS Office.

Responsabilidades

• Develop, validate, and maintain SAS programs for SDTM datasets per CDISC standards.
• Perform independent programming validation and quality control for data integrity.
• Provide statistical programming support including strategies, standards, and data conversion processes.
• Review study protocols, CRFs, and data mappings to support SDTM implementation.
• Contribute to regulatory submissions and ensure alignment with study objectives.
• Review planning documents to ensure programming timelines and objectives.
• Assess impact of protocol amendments and data updates on programming activities.
• Collaborate with internal and external stakeholders on standards, data transfers, and deliverables.
• Ensure regulatory compliance and adherence to SOPs and best practices.
• Identify opportunities to improve efficiency, quality, and standardization across SDTM programming.
• Independently lead programming assignments and mentor junior programmers.

Conhecimentos

SAS programming

Clinical trial data processing

CDISC SDTM

Data mapping

Quality control

Define.xml generation

Pinnacle 21

XML

MS Office

Formação académica

Bachelor's degree in Statistics/Biostatistics/Mathematics/Computer Science/Life Sciences

Ferramentas

Pinnacle 21

XML

Linux/Unix

MS Office

Descrição da oferta de emprego

Key Responsibilities

• Develop, validate, and maintain SAS programs for the creation, validation, and delivery of SDTM datasets in compliance with CDISC standards and study requirements.
• Perform independent programming validation and quality control to ensure the accuracy, consistency, and integrity of SDTM datasets and related deliverables.
• Provide statistical programming support to project teams, including the development of programming strategies, standards, specifications, and data conversion processes.
• Review and interpret study protocols, CRFs, data management documents, and mapping specifications to support SDTM implementation.
• Contribute to the preparation, review, and support of electronic submissions for regulatory agencies.
• Review key planning documents, including Data Review Plans and other study specifications, to ensure alignment with project objectives and programming requirements.
• Assess the impact of protocol amendments, CRF changes, and data updates on SDTM programming activities and timelines.
• Collaborate with internal stakeholders and external vendors on CDISC standards, programming conventions, specifications, data transfers, and deliverables.
• Ensure compliance with regulatory requirements, industry standards, company SOPs, and departmental best practices.
• Identify and implement opportunities to improve efficiency, quality, standardization, and consistency across SDTM programming activities.
• Independently lead and execute programming assignments with minimal supervision while providing guidance to junior programmers as needed.
• Support process improvement initiatives and contribute to the development of reusable macros, standards, and programming utilities.

Required Qualifications

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field.
• 710 years of clinical/statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong proficiency in SAS programming with extensive experience in clinical trial data processing and reporting.
• Strong hands-on experience in CDISC SDTM implementation, mapping, validation, and submission readiness.
• Thorough understanding of clinical trial data structures, relational databases, and clinical data management processes.
• Experience handling source data from various systems, including EDC and external vendor data, and transforming them into SDTM-compliant datasets.
• Strong knowledge of SDTM metadata, mapping specifications, define.xml generation, and data quality review processes.
• Experience with industry tools such as Pinnacle 21, XML, and Microsoft Office.
• Knowledge of regulatory requirements and industry standards related to clinical trial submissions.
• Good understanding of clinical trial methodologies, medical terminology, protocol design, and statistical concepts.
• Strong communication, collaboration, and problem-solving skills with the ability to work effectively in cross-functional teams.

Preferred Qualifications

• Experience supporting regulatory submissions such as NDA, BLA, MAA, and other global health authority filings.
• Knowledge of the drug development lifecycle and global regulatory guidelines.
• Experience with additional programming languages and tools such as R.
• Experience working in a Linux/Unix environment.
• Exposure to automation, process optimization, and standards development initiatives.

Good to Have

• Experience in ADaM dataset development.
• Experience in TLF (Tables, Listings, and Figures) programming.
• Experience supporting submission-ready deliverables and regulatory inspections.
• Knowledge of advanced reporting and visualization tools used in clinical development.