Qureos Mentor

Tango Therapeutics

<div>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:
<ul>
<li>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</li>
<li>Develop, validate, and maintain analysis datasets (SDTM, ADaM), tables, listings, and figures, TLFs) in accordance with regulatory guidelines and internal standards</li>
<li>Review key clinical study or program documents</li>
<li>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</li>
<li>Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)</li>
<li>Collaborate with biostatisticians, data managers, and cross-functional team members to define programming strategies and requirements, establish project timelines, and perform statistical analyses</li>
<li>Author or review SDTM and ADaM specifications to ensure compliant to CDISC standards</li>
<li>Develop SAS or R code, manage macro or utilities library and templates for efficiently preparing, processing, analyzing clinical data, and validating analysis results</li>
<li>Author and review statistical analysis related SOPs</li>
<li>Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis</li>
<li>Additional duties and responsibilities as required</li></ul> 


What You Bring:
<ul>
<li>Bachelor's or master's degree in statistics, life sciences, computer science, or related field with at least 8 years' statistical programming experience</li>
<li>Experience in oncology preferred</li>
<li>Solid understanding of industry standards applicable to clinical study data and regulatory reporting requirements including eCTD and CDISC implementation</li>
<li>Expert level in SAS programming (Base, Macro, STAT, GRAPH, SQL) is essential; with experience delivering complex programming assignments, macros, and analyses</li>
<li>Experience with R is desirable</li>
<li>Extensive experience in clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures</li>
<li>Expertise in the requirements and technology to support electronic submissions</li>
<li>Experience with BLA, NDA/sNDA submissions to FDA/EMA preferred</li>
<li>Strong analytical and communication skills</li></ul> 


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.</div>

Senior Manager, Statistical Programming

<div>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 the team as Manager, Clinical Sciences. In this role, you will support the development, planning, execution, and evaluation of clinical studies to ensure scientific integrity and accurate interpretation of data. You will report to the Senior Medical Director, Clinical Development. 


Your Role:
<ul>
<li>Support the clinical development of investigational oncology therapies by contributing to study design discussions. This includes patient population definitions, endpoint selection, protocol feasibility assessments, and literature research of medical publications to extract data and relevant scientific information</li>
<li>Partner with cross-functional teams to support the timely start-up and execution of clinical trials in accordance with regulatory requirements and Good Clinical Practice (GCP)</li>
<li>Collaborate with data management, clinical operations, biostatistics, pharmacovigilance, and other clinical teams to ensure alignment on study milestones and deliverables</li>
<li>Contribute to the development and review of clinical documents including protocols, informed consent forms, Investigator's Brochures, clinical study reports, and regulatory submission materials</li>
<li>Assist with reviewing and writing other clinical trial documents and publications as needed</li>
<li>Conduct targeted literature reviews and extract relevant data from medical publications to support clinical development strategy and regulatory submissions</li>
<li>Provide clinical and scientific support to clinical sites and CROs, including assistance with protocol training, site communications, and query resolution</li>
<li>Review clinical data in EDC systems including data cleaning, to identify safety signals and trends, summarize findings, and contribute to interim data reviews and study decision making</li>
<li>Collaborate with data management to develop and maintain clinical data review plans, including defining data review schedules, identifying critical data points for monitoring, and establishing processes for ongoing data quality oversight</li>
<li>Prepare clear, concise data summaries and study status updates for internal team meetings and cross-functional review</li>
<li>Perform other related duties and responsibilities as assigned</li></ul> 


What You Bring:
<ul>
<li>MS, PharmD, PhD, RN, or PA degree in a relevant scientific or clinical discipline</li>
<li>At least 5 years' experience in clinical science, or research</li>
<li>At least 2 years' experience in oncology</li>
<li>Understanding of clinical trial design, regulatory guidelines (FDA/ICH), and GCP principles</li>
<li>Strong analytical skills with proficiency in interpretation of clinical data and identification of clinical trends</li>
<li>Excellent written and oral communication skills, with the ability to convey complex scientific concepts clearly</li>
<li>Proven success operating in a high pace, dynamic team setting</li>
<li>Collaborative mindset with eagerness to learn and grow within clinical development</li></ul> 


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.</div>

Manager, Clinical Sciences

<div>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

Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango's clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling. This role is ideal for someone who thrives in a dynamic environment, excels at collaboration, and is passionate about ensuring high-quality clinical data to drive impactful decision-making. 


Your Role:
<ul>
<li>Lead the clinical data management partnership with CROs, ensuring seamless execution of Tango's clinical trials</li>
<li>Provide oversight for fully outsourced data management activities from RFP to final database lock, working closely with CROs to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools</li>
<li>Develop and/or author key data management documents, including database design specifications, edit checks, CRF completion guidelines, and Data Management Plans, ensuring compliance with CDASH and SDTM standards</li>
<li>Partner with cross-functional teams to standardize data collection and reporting processes, enhancing efficiency and data quality</li>
<li>Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders</li>
<li>Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks</li>
<li>Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets</li>
<li>Collaborate with internal and external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure projects are delivered on time and within budget</li>
<li>Participate in study team meetings, providing updates, addressing issues, and ensuring data is effectively collected, reviewed, and analyzed</li></ul> 


What you bring:
<ul>
<li>Bachelor's degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms like Metadata Rave</li>
<li>5-8 years of experience leading the data management of clinical trials, from study start up through database lock, within an industry sponsor, ideally focusing on oncology or rare diseases</li>
<li>Strong vendor management and oversight experience</li>
<li>Solid technical skills across data platforms; programming experience preferred</li>
<li>Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology</li>
<li>Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance</li>
<li>Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data</li>
<li>Experience in regulatory GCP inspections/audits preferred</li>
<li>Experience with Spotfire, elluminate or other data visualization software</li>
<li>Ability to manage multiple projects in a fast-paced environment</li></ul> 


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.</div>

Associate Director, Clinical Data Management

Join Tango Therapeutics and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Tango Therapeutics

ABOUT_COMPANY

Senior Manager, Statistical Programming

Manager, Clinical Sciences

Associate Director, Clinical Data Management