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
In this new role, reporting to the Vice President, Biometrics you will be working with cross‑functional clinical teams responsible for statistical activities across Tango’s clinical programs, including overseeing statistical deliverables outsourced to clinical CROs. This is an exciting opportunity to make an impact in the development of transformative therapies that may change patients’ lives. You will be a good communicator, collaborative, self-motivated, and forward‑thinking.
Your Role:
- You will serve as a biostatistics expert for Tango’s clinical programs
- Provide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studies
- As a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverables
- Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies
- Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
- Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
- Review electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analyses
- Provide statistical input for clinical documents
- Perform QC/QA of statistical deliverables including validation of key analysis results
- Perform ad hoc statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical methods, and interpretation of study results
- Accountable for assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions; provide thorough review for required components of regulatory submissions including appropriate datasets, define files, reviewer's guides, and other relevant documents
- Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
- Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations
- Lead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standards
- Represent Tango regarding statistical issues in meetings with external parties including regulatory agencies and corporate partners
- Support inspection readiness activities as needed
- Develop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug development
- Additional duties and responsibilities as required
What You Bring:
- PhD in statistics or related discipline; MS with appropriate years of directly relevant experience
- At least 8 years’ experience in the pharmaceutical or biotech industry
- Oncology experience required
- Experience in the design, analysis, and reporting of clinical trials
- Experience in INDs, NDAs, MAAs, or other regulatory submissions
- In-depth knowledge of statistical methods for clinical trials
- Knowledge of FDA, EMA, and ICH regulations and guidelines
- Proficient in statistical programming (SAS and R)
- Ability to lead statistical efforts for multiple studies
- Fluent in data standards, including SDTM and ADaM
- Experience in outsourced statistical services provided by CROs
- Ability to work independently and act with initiative to address issues
- Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner
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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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.
