Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of Lyra’s lead product (LYR-210) for the treatment of chronic rhinosinusitis with and without nasal polyps was recently announced and Lyra intends on starting a Phase 3 trial later this year. Lyra’s second development stage product, LYR-220, is expected in the clinic this year. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.
Our team is growing and we are currently recruiting for a Director, 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.
Key Responsibilities Include:
· 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 modelling 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
· Represent Lyra Therapeutics on data safety monitoring boards to oversee clinical studies
· 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
· 5-10 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.