Director, Biostatistics

Company OverviewTango Therapeutics is a biotechnologycompanydedicated 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 at201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.SummaryIn this new role, reporting to the Senior Director, 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 programsProvide strategic input to optimize trial designs in early phase dose escalation studies and late phase registrational studiesAs a biostatistics representative, proactively collaborate with internal and external CRO team members to coordinate the planning and execution of statistical deliverablesConduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studiesContribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principlesAuthor or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverablesReview electronic case report form (eCRF) designs to ensure data collection meets the requirements of statistical analysesProvide statistical input for clinical documentsPerform QC/QA of statistical deliverables including validation of key analysis resultsPerform ad hoc statistical analyses as neededContribute to clinical study reports, including authoring of statistical methods, and interpretation of study resultsAccountable 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 documentsAddress statistical questions/comments from FDA and other regulatory agencies, or IRB/ECsSupport and contribute to the preparation of publications, including manuscripts, posters, and oral presentationsLead standardization and process improvement efforts for Biostatistics function, and contribute to cross-functional process improvement efforts including the definition of biostatics templates and standardsRepresent Tango regarding statistical issues in meetings with external parties including regulatory agencies and corporate partnersSupport inspection readiness activities as neededDevelop and maintain advanced competencies in statistical methodology and advanced trial designs, particularly in oncology drug developmentAdditional duties and responsibilities as requiredWhat You Bring:PhD in statistics or related discipline; MS with appropriate years of directly relevant experienceAt least 10 years’ experience in the pharmaceutical or biotech industryOncology experience requiredExperience in the design, analysis, and reporting of clinical trialsExperience in INDs, NDAs, MAAs, or other regulatory submissionsIn-depth knowledge of statistical methods for clinical trialsKnowledge of FDA, EMA, and ICH regulations and guidelinesProficient in statistical programming (SAS and R)Ability to lead statistical efforts for multiple studiesFluent in data standards, including SDTM and ADaMExperience in outsourced statistical services provided by CROsAbility to work independently and act with initiative to address issuesExcellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner#LI-hybridWe 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 $191,200—$286,800 USD