Senior Statistical Programming Lead

5 days ago

Étreux, Hauts-de-France, United States Tango Therapeutics Full time

Company Overview

Tango Therapeutics is a pioneering biotechnology company dedicated to harnessing the power of precision medicine for cancer treatment. Our approach, centered around synthetic lethality, enables us to discover and develop novel therapies that target critical targets in cancer.

We are committed to expanding the universe of precision oncology targets into novel areas, including tumor suppressor gene loss and its impact on immune cell evasion.

Opportunity Summary

We are seeking an experienced Senior Statistical Programming Lead to join our clinical development operations team. In this role, you will be accountable for overseeing program-specific statistical programming activities, maintaining programming infrastructure, and ensuring compliance with SOPs to deliver high-quality and timely results.

You will serve as the team's point person for statistical programming, collaborating closely with the Head of Statistical Programming to contribute to departmental strategies and drive the development of departmental procedures, training, and standards.

Your Role:

  • Lead and manage statistical programming activities for clinical trials and studies, ensuring timely and high-quality deliverables for CSR, publications, presentations, reports, and health authority submissions.
  • 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 We Offer:

  • $130,000 - $160,000 per year, depending on experience.
  • 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 SAS programming skills (Base, Macro, STAT, GRAPH, SQL) are 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 datasets, 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.

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