Senior Manager, Statistical Programming

Tango Therapeutics-posted 24 days ago

Full-time • Mid Level

Boston, MA

101-250 employees

Chemical Manufacturing

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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.

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

Bachelor's or master's degree in statistics, life sciences, computer science, or related field with at least 8 years' statistical programming experience
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
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
Strong analytical and communication skills

Experience in oncology preferred
Experience with R is desirable
Experience with BLA, NDA/sNDA submissions to FDA/EMA preferred

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