Head of Biometrics - Flare Therapeutics : Job Details

Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare's team has uncovered 'switch sites,' druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare's drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of research programs that address well-validated genetically-defined transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation.We are a collective of brilliant fires, trailblazing a path to conquer transcription factors and create cutting-edge medicines for patients. We embrace diversity in all its forms, experiences, and viewpoints. We are inspired by the unknown and willing to take risks. We are passionate about the science we pursue and compassionate about the patients it stands to benefit. And we respect, value, and believe in each other.Reporting to the Chief Medical Officer, the successful Biometrics candidate will serve an overarching role to position Biostatistics, Statistical Programming, and Data Management as a well-coordinated and innovative function, ensuring strategic planning and close cross-functional communication to drive programs and clinical trials forward. As appropriate, the Head of Biometrics will manage both internal resources and oversee and review work products of external Biometric vendors to ensure the validity and reproducibility of clinical and translational data.In this role you will---

• Establish and lead a high-performance biometrics function consisting of internal and external (biometrics consultants or CRO's) to support clinical development with a focus on quality and excellence.
• Oversee biometrics activities including strategy, program support, workforce planning, best practices, compliance, timely and high-quality study deliverables and application of emerging science.
• Be accountable for data management and statistical programming; in collaboration with the medical team, and provide insight to the data.
• Assure that biometrics activities comply with all 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 function SOPs and best working practice guides.
• Identify vendor requirements and provide technical perspective in the evaluation/selection of vendors.
• Author relevant sections of regulatory submissions and represent the company at regulatory agencies, and participate in writing, review and finalization of abstracts and manuscripts for publication.
• Represent the company on data safety monitoring boards and safety review committees to oversee clinical studies.
• Develop and retain key talent by managing and mentoring biostatisticians, programmers, data managers and other personnel as needed to grow a cohesive unit.
• 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 including internal and outsourced functions: clinical pharmacology, translation medicine/biomarkers, medical affairs and medical writing to support clinical development.About you---
  • You have a PhD or Masters in Biostatistics.
  • You have a minimum of 10 years of experience in pharma or biotech; at least 5 years of oncology drug development.
  • You have strong methodological technical and analytical expertise, with leadership experience in both early- and late-stage development contributing to governance milestones, strategy, health authority interactions, protocols and submissions.
  • You have a proven track record of effective leadership experience including managing reports, teams, taskforces, CRO's or initiatives.
  • You understand oncology data review, have participated in a leadership role on a team with responsibility for data management.
  • You have proven knowledge and expertise in statistics, statistical programming and data management, and their application to clinical trials.
  • You have knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics and data handling.
  • You may have presented to regulatory authorities in the past.
  • You might also have prior registration and NDA/BLA experience.
  • You have sound knowledge of clinical database management, statistical programming languages (including SAS), software.
  • You possess excellent communication and presentation skills.
  • You are known as a team player, with ability to work successfully across functions and with all levels within the organization.Flare is proud to foster a diverse, equitable and inclusive company culture that embraces all people that are essential to who we are, what we do and what we believe. Flare Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #J-18808-Ljbffr