Senior Manager, Statistical Programming
Tango Therapeutics
2 hours ago
Remote friendly (Boston, MA)
United States
$157,600 - $236,400 USD yearly
Clinical Research and Development
Your Role
- 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, 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; manage macro library and templates to efficiently prepare, process, analyze clinical data, and validate 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 teams to define programming strategies and requirements, establish project timelines, and perform statistical analyses
- Author or review SDTM and ADaM specifications to ensure compliance with CDISC standards
- Author and review statistical analysis related SOPs
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
What You Bring
- 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 clinical study 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, and analyses
- Experience with R (desirable)
- Extensive experience in clinical studies including programming and validation of SDTM and ADaM datasets, tables, listings, and figures
- Expertise in requirements and technology to support electronic submissions
- Experience with BLA and NDA/sNDA submissions to FDA/EMA (preferred)
- Strong analytical and communication skills
Salary range
- $157,600—$236,400 USD
- 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, 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; manage macro library and templates to efficiently prepare, process, analyze clinical data, and validate 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 teams to define programming strategies and requirements, establish project timelines, and perform statistical analyses
- Author or review SDTM and ADaM specifications to ensure compliance with CDISC standards
- Author and review statistical analysis related SOPs
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
What You Bring
- 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 clinical study 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, and analyses
- Experience with R (desirable)
- Extensive experience in clinical studies including programming and validation of SDTM and ADaM datasets, tables, listings, and figures
- Expertise in requirements and technology to support electronic submissions
- Experience with BLA and NDA/sNDA submissions to FDA/EMA (preferred)
- Strong analytical and communication skills
Salary range
- $157,600—$236,400 USD