Associate Director, Statistical Programming

Tango Therapeutics

Boston, MA

On-site

Who this role is best for

Strong fit for experienced SAS programmers with a background in oncology who can lead and manage complex clinical trial programming activities.

Best fit for

Experienced SAS programmers with a background in oncology and regulatory submissions
— “Experience with BLA or NDA/sNDA submissions to FDA/EMA required”
Candidates who can lead and manage CRO teams and deliver high-quality, timely outputs
— “Manage and provide oversight of CROs to ensure high-quality statistical analysis deliverables”
Individuals with a track record of developing and maintaining SDTM and ADaM datasets
— “Extensive experience in early-phase clinical studies including programming and validation of SDTM and ADaM data sets”

Things to consider

The role requires significant expertise in electronic submission standards and CDISC compliance
— “Expertise in the requirements and technology to support electronic submissions”
Candidates must be able to work in Boston, as the location is explicitly specified
— “Tango's labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts”

How to stand out

Highlight your experience with complex SAS programming and macro library management
— “Perform complex statistical analyses and simulations using SAS”
Emphasize your ability to author or review SDTM and ADaM specifications
— “Author and/or review statistical analysis related SOPs”
Demonstrate your ability to collaborate with biostatisticians and data managers
— “Collaborate with biostatisticians, data managers, and cross-functional team members”

Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

high_quality_outputs
timely_deliverables
regulatory_submissions
data_compliance

Typical background

biostatisticsclinical_trialsdata_engineering

Skills & requirements

Required

Sas_programmingStatistical_analysisClinical_data_managementRegulatory_complianceCdisc_standardsData_interpretation

Preferred

BiostatisticsClinical_trials

Stack & domain

SASCdiscEctdStatistical ProgrammingClinical TrialsData AnalysisCommunicationTeamworkLeadershipBiotechnologyPharmaceuticalsClinical Research

About the role

Original posting from Tango Therapeutics via Greenhouse

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
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

Source: Tango Therapeutics careers (Greenhouse)