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Principal Stat Programmer
ConfidentialPune30+ days ago
Job descriptionCollaborate with biostatistics and programming teams to establish SOPs, guidelines, policies, and procedures. Develop and optimize programming tools and macros for standardization and efficiency. Serve as an SME on CDISC standards : Provide guidance and training to Biostatistics and other departments on CDISC usage. Conduct compliance reviews of project deliverables (SDTM, ADaM, DEFINE.XML, and other regulatory documents). Participate in industry standards organizations and provide updates to the Biometrics department. Transfer deliverables and coordinate with cross-functional teams for project execution. Mentor junior programmers and support their understanding of CDISC standards and clinical trial processes. Perform other work-related duties and minimal travel as required. Undergraduate degree in a scientific or statistical discipline (or equivalent combination of education and experience). Extensive SAS or equivalent programming experience in clinical trial environments. Knowledge and hands-on experience with CDISC standards (SDTM, ADaM, DEFINE.XML). Regulatory submission experience preferred. Proven experience leading multiple complex or global projects. Experience mentoring others in clinical trial processes and CDISC standards. Excellent written and verbal communication skills; proficiency in English. SAS programming and clinical data analysis CDISC Standards (SDTM, ADaM, DEFINE.XML) Clinical trial data management and regulatory compliance SOP development and process standardization Mentoring and team leadership Regulatory submission experience Problem-solving and analytical thinking Communication and presentation skills Cross-functional collaboration
Job Summary :
- Serve as a technical subject matter expert (SME) for CDISC and other industry and regulatory standards.
- Contribute to the development of standardized programming tools, macros, and SOPs for efficiency and compliance.
- Lead multiple complex and / or global clinical trial programming projects, mentoring and guiding statistical programming teams.
- Ensure compliance of programming deliverables with CDISC standards, regulatory requirements, and internal guidelines.
Key Responsibilities :
Qualifications :
Skills Required :
Skills Required
Sas Programming, Data Analysis, Clinical Trials, Statistical Modeling, cdisc standards , R Programming
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Principal Programmer • Pune
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