Senior Manager, Statistical Programming

Role Summary

Tango has an exciting opportunity to join our growing Biometrics team as a Senior Manager, Statistical Programming, reporting to the Senior Director of Statistical Programming. In this role, you will be responsible for study-specific statistical programming activities, maintaining programming infrastructure, and ensuring compliance with SOPs to deliver high-quality, timely outputs.

Responsibilities

• Lead the statistical programming activities for clinical trials and studies, ensuring high-quality and timely deliverables for CSR, publications, presentations, various reports for health authority submissions, clinical data review, and ad hoc analysis
• Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, and figures, 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 library and templates for efficiently preparing, processing, analyzing clinical data and validating analysis results
• Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
• Collaborate with biostatisticians, data managers, and cross-functional team members to define programming strategies and requirements, establish project timelines, and perform statistical analyses
• Author or review SDTM and ADaM specifications to ensure compliant to CDISC standards
• Develop SAS or R code, manage macro or utilities library 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‚Äôs or master‚Äôs degree in statistics, life sciences, computer science, or related field with at least 8 years‚Äô 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

• Statistical programming
• SAS (Base, Macro, STAT, GRAPH, SQL)
• R programming
• SDTM/ADaM data standards
• CDISC regulatory submissions
• Data analysis and reporting
• Cross-functional collaboration

Education

• Bachelor‚Äôs or master‚Äôs degree in statistics, life sciences, computer science, or related field

Additional Requirements

• Location in Boston area or willing to work in a hybrid/onsite setting as required