Associate Director, Statistical Programming
About The Position
Tango Therapeutics is a clinical-stage biotechnology company focused on discovering novel drug targets and developing precision medicines for cancer. The Associate Director, Statistical Programming joins the growing Biostatistics team and reports to the Senior Director of Statistical Programming. This role leads study-specific statistical programming activities, maintains programming infrastructure, and ensures compliance with SOPs to deliver high-quality, timely outputs. The position supports clinical trials and studies through statistical programming for clinical study reports, publications, presentations, health authority submissions, clinical data review, and ad hoc analyses. Work may be performed internally or through CRO partners. The role develops and validates clinical datasets and statistical outputs, performs analyses and simulations, supports regulatory submissions, contributes to secure statistical computing infrastructure, and collaborates with biostatistics, data management, and other cross-functional teams.
Requirements
- Bachelor’s or Master’s degree in statistics, life sciences, computer science, or a related field.
- At least 8 years of statistical programming experience.
- Solid understanding of industry standards for clinical study data and regulatory reporting requirements, including eCTD and CDISC implementation.
- Expert-level SAS programming expertise in Base, Macro, STAT, GRAPH, and SQL, including 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 datasets, tables, listings, and figures.
- Experience managing CROs for outsourced statistical programming activities.
- Expertise in requirements and technology supporting electronic submissions.
- Experience with BLA or NDA/sNDA submissions to FDA/EMA.
- Strong analytical and communication skills.
Nice To Haves
- Experience in oncology.
Responsibilities
- Lead and manage statistical programming activities for clinical trials and studies, delivering outputs for clinical study reports, publications, presentations, health authority submissions, clinical data review, and ad hoc analyses, either internally or through CRO partners.
- Develop, validate, and maintain SDTM and ADaM analysis datasets, tables, listings, and figures 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 libraries and templates for preparing, processing, and analyzing clinical data and validating analysis results.
- Provide statistical programming expertise for regulatory submissions, including FDA and EMA submissions and eCTD standards.
- 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 oversee CROs to ensure high-quality statistical analysis deliverables, including datasets and TLFs, within timeline and budget.
- Author or review SDTM and ADaM specifications for compliance with CDISC standards.
- Develop SAS code and manage macro libraries and templates for clinical data preparation, processing, analysis, and validation.
- Author and/or review statistical analysis-related SOPs.
- Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis.
- Perform additional duties and responsibilities as required.
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What This Job Offers
Job Type
Full-time
Career Level
Director
