Senior Manager, Statistical Programming
Tango Therapeutics
5 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Senior Manager, Statistical Programming
Responsibilities:
- Lead statistical programming activities for clinical trials and studies; deliver high-quality/timely outputs for CSR, publications, presentations, health authority submissions, clinical data review, and ad hoc analysis
- Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, figures, and TLFs per regulatory guidelines and internal standards
- Review key clinical study/program documents
- Perform complex statistical analyses and simulations using SAS or R; manage macro libraries and templates to prepare, process, analyze clinical data, and validate results
- Provide statistical programming expertise for regulatory submissions (e.g., FDA, EMA), including eCTD standards
- Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies/requirements, establish project timelines, and perform analyses
- Author or review SDTM and ADaM specifications to ensure CDISC compliance
- Develop SAS or R code; manage macro/utilities libraries and templates for analysis preparation and validation
- Author and review statistical analysis-related SOPs
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
Qualifications:
- Bachelor’s or master’s degree in statistics, life sciences, computer science, or related field with at least 8 years of statistical programming experience
- Oncology experience preferred
- Solid understanding of clinical data and regulatory reporting standards, including eCTD and CDISC implementation
- Expert-level SAS programming (Base, Macro, STAT, GRAPH, SQL) essential; experience delivering complex programming assignments/macros/analyses
- R experience desirable
- Extensive clinical studies experience, including programming and validation of SDTM/ADaM datasets, tables, listings, and figures
- Expertise supporting electronic submissions
- BLA and NDA/sNDA submissions to FDA/EMA preferred
- Strong analytical and communication skills
Responsibilities:
- Lead statistical programming activities for clinical trials and studies; deliver high-quality/timely outputs for CSR, publications, presentations, health authority submissions, clinical data review, and ad hoc analysis
- Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, figures, and TLFs per regulatory guidelines and internal standards
- Review key clinical study/program documents
- Perform complex statistical analyses and simulations using SAS or R; manage macro libraries and templates to prepare, process, analyze clinical data, and validate results
- Provide statistical programming expertise for regulatory submissions (e.g., FDA, EMA), including eCTD standards
- Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies/requirements, establish project timelines, and perform analyses
- Author or review SDTM and ADaM specifications to ensure CDISC compliance
- Develop SAS or R code; manage macro/utilities libraries and templates for analysis preparation and validation
- Author and review statistical analysis-related SOPs
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
Qualifications:
- Bachelor’s or master’s degree in statistics, life sciences, computer science, or related field with at least 8 years of statistical programming experience
- Oncology experience preferred
- Solid understanding of clinical data and regulatory reporting standards, including eCTD and CDISC implementation
- Expert-level SAS programming (Base, Macro, STAT, GRAPH, SQL) essential; experience delivering complex programming assignments/macros/analyses
- R experience desirable
- Extensive clinical studies experience, including programming and validation of SDTM/ADaM datasets, tables, listings, and figures
- Expertise supporting electronic submissions
- BLA and NDA/sNDA submissions to FDA/EMA preferred
- Strong analytical and communication skills