Vice President, Biostatistics & Programming

Company: Jounce Therapeutics, Inc.
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Role Description:The Biostatistics and Programming team at Jounce Therapeutics is hiring! We are seeking a VP level leader who will be responsible for managing a group of statisticians and programmers t to support all statistical and programming needs for Jounce programs from pre-IND through BLA. As a member of the Clinical Development and Regulatory Affairs Leadership Team, the ideal candidate will play a key role in strategic planning for all Jounce clinical programs.
Responsibilities:

• Provide strategic and statistical expertise in design of clinical development plans, clinical study protocols, analysis, and clinical study reports for phase 1 trials through BLA
• Functional Representative in key internal facing senior meetings such as program teams, clinical development and regulatory affairs leadership team, portfolio steering team and management team, as well as more external facing meetings such as Board of Directors.
• Summarize and present statistical strategies and/or key study results to internal governance bodies, external collaborators including business partners and regulatory agencies
• Plan and oversee deliverables and timeline of study readouts including regular data reviews, predefined interim analysis and final analysis to support decision making
• Work closely with clinical development, clinical operations, pharmacovigilance, clinical pharmacology, translational science, and medical writing to support clinical study planning and execution
• Manage an existing team of statisticians and statistical programmers and support and foster their professional development needs and build the team as Jounce programs progress towards BLAs.
• Represent Biostatistics function in the program team and contribute to cross-functional decision making on study design, endpoint selection, data collection, and analysis strategies, ensuring alignment with study objectives
• Perform sample size calculation for continuous, dichotomous, and time to event endpoints in various study design
• Perform simulation studies to explore the statistical operating characteristics in study design phase including innovative/adaptive designs
• Proactively identify and anticipate technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research, and approve and implement alternative analysis strategies or other recommendations to address these issues
• Evaluate performance of patient enrichment biomarkers including metrics for AUC, PPV, NPV and determination of assay thresholds for use in prospective trials
• Write the statistical section in clinical protocols
• Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation
• Develop exploratory statistical analysis plans for predictive and pharmacodynamic biomarkers and help develop companion diagnostics strategies for the program
• Interpret study results and write (or at least QC and review) statistical summary reports of study results
• Perform statistical analyses to support publications in medical conferences
• Collaborate with Jounce data management team to support QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
• Support development of eCRFs and be responsible for specs for IVRS, SDTM, and ADaM
• Contribute to the implementation, maintenance, and evolution of the systems and processes involved in the collection, review and analysis of clinical and translational data
• Responsible for statistical programming activities including the development of standard statistical documents such as TLFs, Programming specs (e.g. SDTM and ADaM), SAS macros, and SOPs
• Develop proper resources and process regarding hardware, software, SOP and work instructions to provide effective support to clinical studies, and ascertain needs for potential program development of novel statistical methodology Requirement/Qualifications:
  • PhD or equivalent in Statistics or Biostatistics required
  • 12+ years of experience in oncology pharmaceutical development and applied statistics/statistical consulting required
  • 5+ years of management experience leading biostatistics and programming groups
  • Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
  • Knowledge of FDA, EMA, and ICH guidance for drug development pertaining to statistics
  • Experience with the relevant regulatory requirements for data management and supporting SOPs
  • Experience in use of commercial clinical data management systems/EDC products (e.g. RAVE, Inform, TrialMaster, etc)
  • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
  • Familiar with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
  • Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency
  • Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
  • Enthusiastic, passionate about bringing important new therapies to patients with cancer, and willing to roll up his or her sleeves to do whatever it takes while building the right team of outstanding statistics and data management professionals.
  • Effective communication skills and able to explain complex statistical approaches to non-statisticians. Company OverviewJounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce's highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with JTX-4014, Jounce's internal PD-1 inhibitor, or pembrolizumab is currently enrolling patients with advanced solid tumors. Jounce's most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce's broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com. Diversity and Inclusion StatementJounce strives to create a workplace that reflects the diversity of cancer patients, and where all feel included and valued because of their differences. Actively including people who add to our culture and enhance our values leads to better decisions and outcomes for those we serve -patients, all patients. Beyond our walls, our focus is on addressing inequities in opportunities for STEM education, careers opportunities in Biotech, and access to cancer care. Equal Opportunity Employer Jounce Therapeutics is an equal opportunity employer and does not discriminate in its employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs. We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

Keywords: Jounce Therapeutics, Inc., Cambridge , Vice President, Biostatistics & Programming, Executive , Cambridge, Massachusetts