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 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)
Participate in Tango’s Data Governance Team to build and maintain secure statistical computing and programming infrastructure
Collaborate with biostatisticians, data managers, and cross-functional team members to define programming strategies and requirements, establish project timelines, and perform statistical analyses
Manage and provide oversight of CROs to ensure high-quality statistical analysis deliverables (datasets, TLFs, etc.) within timeline and budget
Author or Review SDTM and ADaM specifications to ensure compliance to CDISC standards
Review key clinical study or program documents
Develop SAS code, manage macro library and templates for efficiently preparing, processing, analyzing clinical data, and validating analysis results
Author and/or 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
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
Solid understanding of industry standards applicable to clinical study data and regulatory reporting requirements including eCTD and CDISC implementation
Expert level expertise in SAS programming (Base, Macro, STAT, GRAPH, SQL) is essential; with experience delivering complex programming assignments, macros, and analyses
Experience with R and Python
Extensive experience in early-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
Experience managing CROs for outsourced statistical programming activities
Expertise in the requirements and technology to support electronic submissions
Experience in oncology preferred
Experience with BLA or NDA/sNDA submissions to FDA/EMA required
Strong analytical and communication skills
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Salary range
$172,000—$258,000 USD
