- Master's Degree
- Doctoral Degree
- Project Management
- Statistical Analysis
- FDA Regulations
Role / Responsibilities:
This position is a project level statistician and will support clinical trials in Oncology. The successful candidate will collaborate effectively with study teams including clinician, clinical pharmacologist and translational oncologist to design studies, develop protocols, write statistical analysis plans, perform statistical analysis, write reports and present results summarizing findings.
Represent the biostatistics function in support of clinical and translational science activities related to specific trials.
Provide rigorous statistical input into study design, study protocol, statistical analysis plans, interpretation of statistical results, business development plans, submission plans, and in support of regulatory submissions.
Author, co-author or review the protocol, statistical analysis plan, Top Line Report, Clinical Study Report, and other clinical trial documents, ensuring accurate statistical deliverables.
Provide planning, delivery and communication of statistical analyses, data presentations, and support for publication activities and scientific presentations
Implement project level analysis and reporting standards. Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at project level.
Plan and direct study-level analysis and reporting activities (e.g., mock shells, tables, figures, and listings) including review and QC of work by programmers.
Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review, QC and approve key statistical vendor deliverables.
Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
Consider and evaluate alternative analysis methodology and data presentation techniques.
MS or PhD in statistics or biostatistics with at least 5 years (8 years for MS ) of biopharmaceutical industry experience, including minimum of 2-3 years of oncology experience
Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
Working knowledge of statistical programming languages (including SAS and/or R), software, techniques, and processes.
Excellent oral and written communications skills.
Strong project management skills.
Strong collaborative skills and ability to work with a cross-functional team.
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.
To apply, please visit https://careers-jouncetx.icims.com/.
Jounce 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. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within the human tumor microenvironment to prioritize targets, and then identifies related biomarkers designed to match the right immunotherapy to the right patient. Jounce is developing two clinical-stage programs as well as advancing and building out its broad and wholly-owned discovery pipeline of immuno-oncology targets, including those expressed on T-regulatory cells, macrophages and stromal cells. Jounce’s lead product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS and is currently being assessed in a Phase 2 clinical trial. JTX-4014 is a PD-1 inhibitor intended for use in combination with future pipeline products, and Jounce has completed enrollment in the JTX-4014 Phase 1 clinical trial. In addition, Jounce has exclusively licensed worldwide rights to JTX-8064, a LILRB2 receptor antagonist, to Celgene. For more information, please visit www.jouncetx.com.