Manager - Statistical Programming in Hyderabad, भारत

Responsibilities

• Lead statistical programming for integrated datasets, pooled analyses, and reporting across assigned projects
• Create and maintain programming documentation including pooled ADaM dataset specifications following standards
• Support electronic data package creation and review for regulatory submissions ensuring compliance standards
• Coordinate with cross-functional teams on disclosure datasets and regulatory submission deliverables
• Develop technical tools and programming solutions to improve efficiency and maintain compliance

Requirements

• Master's or Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, or Life Science
• 7+ years programming experience with clinical trial data in pharmaceutical or biotechnology industry
• Proven expertise in FDA, EMA, PMDA, and CDISC regulatory submission standards
• Advanced SAS programming proficiency including Base, Stat, Macro, and Graph modules
• Strong knowledge of SDTM, ADaM, Define-XML, and Pinnacle 21 tools
• Team leadership and project management experience with ability to guide direct reports
• eCTD regulatory submission format knowledge and complex problem-solving abilities