Senior Manager, Statistical Programming

Role Summary

Senior Manager, Statistical Programming oversees study-specific statistical programming activities, maintains programming infrastructure, and ensures compliance with SOPs to deliver high-quality, timely outputs. Reports to the Senior Director of Statistical Programming.

Responsibilities

• Lead the statistical programming activities for clinical trials and studies, ensuring high-quality and timely deliverables for CSR, publications, presentations, health authority submissions, clinical data review, and ad hoc analyses
• Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, and figures, and TLFs in accordance with regulatory guidelines and internal standards
• Review key clinical study or program documents
• Perform complex statistical analyses and simulations using SAS or R to support clinical trial design and data interpretation; manage macro libraries and templates for efficiently preparing, processing, and analyzing clinical data and validating analysis results
• Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
• Author or review SDTM and ADaM specifications to ensure compliance with CDISC standards
• Develop SAS or R code, and manage macro or utilities libraries and templates for efficiently preparing, processing, analyzing clinical data, and validating analysis results
• Author and review statistical analysis related SOPs
• Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
• Additional duties and responsibilities as required

Qualifications

• Bachelor’s or master’s degree in statistics, life sciences, computer science, or related field with at least 8 years’ statistical programming experience
• Experience in oncology preferred
• Solid understanding of industry standards applicable to clinical study data and regulatory reporting requirements including eCTD and CDISC implementation
• Expert level in SAS programming (Base, Macro, STAT, GRAPH, SQL) is essential; with experience delivering complex programming assignments, macros, and analyses
• Experience with R is desirable
• Extensive experience in clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
• Expertise in the requirements and technology to support electronic submissions
• Experience with BLA, NDA/sNDA submissions to FDA/EMA preferred
• Strong analytical and communication skills

Skills

• Proficiency in SAS programming (Base, Macro, STAT, GRAPH, SQL)
• Experience with R
• Knowledge of CDISC SDTM and ADaM standards
• Experience supporting electronic submissions (eCTD) and regulatory submissions
• Strong analytical and communication skills
• Ability to collaborate with biostatisticians, data managers, and cross-functional teams

Education

• Bachelor’s or master’s degree in statistics, life sciences, computer science, or related field