Associate Director, Statistical Programming

tangotherapeutics

Boston (MA)

On-site

USD 172,000 - 258,000

Full time

4 days ago
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Job summary

Tango Therapeutics is seeking an Associate Director, Statistical Programming to lead study-specific statistical programming, maintain infrastructure, and ensure SOP compliance for timely, high-quality outputs. This role reports to the Senior Director of Statistical Programming and sits on the Biostatistics team.

You will develop SDTM/ADaM analyses, validate datasets, and support regulatory submissions (FDA/EMA). Collaboration with statisticians, data managers, and CROs is essential.

Qualifications

  • Bachelor's or Master's degree in statistics, life sciences, computer science, or related field.
  • At least 8 years' statistical programming experience in clinical trials.
  • Expert SAS programming (Base, Macro, STAT, GRAPH, SQL) with CDISC SDTM/ADaM experience.
  • Experience with R and Python.
  • Experience managing CROs.
  • Experience with eCTD electronic submissions.

Responsibilities

  • Lead and manage statistical programming for trials and CSR.
  • Develop, validate, and maintain SDTM/ADaM datasets, tables, listings, and figures.
  • Review key clinical study or program documents.
  • Perform complex statistical analyses and simulations using SAS; manage macro library and templates.
  • Provide expertise in regulatory submissions (FDA/EMA, eCTD).
  • Collaborate with biostatisticians and data managers to define programming strategies.

Skills

Statistical programming
Leadership
Regulatory submissions
Cross-functional collaboration

Education

Bachelor's or Master's degree in statistics, life sciences, computer science, or related field

Tools

SAS
R
Python
CDISC SDTM/ADaM

Job description

Company Overview

Tango Therapeutics is a clinical-stage 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.

Tango's labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary

Tango 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
Equal Opportunity Statement

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

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