SummaryTango has an exciting opportunity to join our growing Biostatistics team as an Associate Director, 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.
Your Role- Lead and manage 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 either internally or through CRO partners
- 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
Salary range
$172,000-$258,000 USD
