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 opportunity to join our growing Biometrics team as a Senior Manager, 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 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
- 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 or R 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)
- Collaborate with biostatisticians, data managers, and cross-functional team members to define programming strategies and requirements, establish project timelines, and perform statistical analyses
- Author or review SDTM and ADaM specifications to ensure compliant to CDISC standards
- Develop SAS or R code, manage macro or utilities library and templates for efficiently preparing, processing, analyzing clinical data, and validating analysis results
- Author and 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
- Experience in oncology preferred
- 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 is desirable
- Extensive experience in clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
- 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
#LI-ONSITE
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.
Top Skills
What We Do
Tango Therapeutics is a biotechnology company discovering and developing novel medicines targeting cancer vulnerabilities to deliver transformational new therapies for patients.
Tango was launched in 2017 with a $55 million Series A investment from Third Rock Ventures. The company has established a robust product engine that leverages advances in DNA sequencing and CRISPR-based target discovery to generate breakthrough medicines that have the potential to provide deeper, more sustained benefit than today’s targeted therapies, and extend the benefit of available immuno-oncology agents.
Tango Therapeutics is focused on three areas of drug development, each in well-defined patient populations currently lacking effective treatment options, and each with hallmarks of cancer that have not been targeted yet. These include: loss of tumor suppressor gene function; multiple oncogenic drivers; and immune evasion.
What fuels each of Tango’s programs is an increasingly sophisticated ability to utilize synthetic lethality - the interaction between two genes that causes cell death when both are inactivated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. This approach leaves normal cells largely unaffected, with the potential to greatly enhance anti-tumor efficacy and reduce associated toxicity.
Tango’s success will be driven by its depth of understanding of the genetic subtypes of cancer, and corresponding insights into novel drug targets and combinations uniquely relevant to each subtype. By shaping discovery efforts in this way, Tango has the potential to reach the clinic quickly, and with a clear plan for identifying the patients most likely to benefit from each new treatment, an approach that could increase both speed and probability of success in translating novel target discoveries into transformational new medicines for patients.
