Associate Director, Statistical Programming

Company: Tango Therapeutics
Location: Boston
Posted on: November 6, 2024

Job Description:

Company Overview
Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.
This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.
Summary
Tango has an exciting new opportunity to join our growing clinical development operations team as Associate Director, Statistical Programming. This role is accountable for program specific statistical programming activities and oversight related activities by vendors in clinical development, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. This position serves as the team point person for statistical programming. You will assist the Head of Statistical Programming to contribute to departmental strategies and help drive the development and continuous improvement of departmental procedures, training, and standards.
Your Role:

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• You will 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 with CDISC standards.
  
• 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:
  
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  • 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 in SAS programming (Base, Macro, STAT, GRAPH, SQL) is essential; with experience delivering complex programming assignments, macros, and analyses.
    
  • Experience with R and Python is desirable.
    
  • Experience in oncology preferred.
    
  • 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 with BLA, NDA/sNDA submissions to FDA/EMA preferred.
    
  • 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.
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Keywords: Tango Therapeutics, Portland , Associate Director, Statistical Programming, Executive , Boston, Maine