Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.
We are currently recruiting for a Vice President, Biostatistics. Reporting to the SVP, Clinical Affairs, the successful Biostatistics candidate will serve an overarching role to position Biostatistics and Statistical Programming as a well-coordinated and innovative function at Lyra Therapeutics, ensuring strategic planning and close cross-functional communication to drive programs forward. Our ideal candidate has a strong methodological, technical and analytical expertise, with leadership experience in both early and late development contributing to governance milestones, strategy, health authority interactions, protocols and submissions.
- Establish and lead a high-performance biometrics capability to support clinical development activities with a focus on quality and excellence
- Oversee biometrics activities including strategy, program support, personnel/consultant/vendor oversight, best practices, compliance, timely study deliverables and application of emerging science
- Assure that biometrics activities comply with health authority regulations
- Lead or support technology-based initiatives to support clinical development with data visualization tools or other technologies
- Apply innovative approaches to study design, analysis, data modeling and exploration, and presentation methodologies from phase 1 to registration studies
- Lead development of biometrics department SOPs and best working practice guides
- Lead the review and ensure accuracy of the STDM and AdAM datasets
- Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors
- Author relevant sections of regulatory submissions and represent Lyra Therapeutics at regulatory agencies, and participates in writing, review and finalization of abstracts and manuscripts for publication
- Anticipate and communicate the project level and the study level resource and quality issues that may impact deliverables or timelines, propose and implement solutions, escalate issues to management as appropriate
- Ensure development and implementation of departmental standards and process improvements
- Work collaboratively with other quantitative disciplines to support clinical development
- PhD in Biostatistics, Mathematics or a related field
- 10+ years of experience in the pharmaceutical or biotech industries
- Strong methodological technical and analytical expertise, with leadership experience in both early and late development contributing to governance milestones, strategy, health authority interactions, protocols and submissions
- Proven track record of effective leadership experience including managing reports, teams, taskforces or initiatives
- Proven knowledge and expertise in statistics, statistical programming and data management, and its applications to clinical trials
- Knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics and data handling
- Prior registration and IND/NDA/BLA experience
- Sound knowledge of clinical database management, statistical programming languages (including SAS), software
- Excellent communication and presentation skills; a team player, with ability to work successfully across functions
- Experience with translational data analysis, managing biostatistics, statistical programming and data management preferred
- Experience with outsourcing biometrics activities, and in overseeing services provided by CROs and contractors preferred
At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit cover letter and CV.
Please visit www.lyratx.com for more information.