San Francisco, CA
QED therapeutics – a BridgeBio company, focuses on precision medicine for FGFR-driven cancers and diseases.
With singular focus, QED is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders.
FGFR=fibroblast growth factor receptor.
- Developing and retaining a highly effective statistics, statistical programming, and data management team.
- Strategically partner with Clinical Development, Regulatory, and Clinical Operations expertise areas to provide drug development leadership on the design and execution of robust clinical development plans for novel therapeutics.
- Leverage advances in the field and, where appropriate, employ innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials.
- Identify and implement solutions to statistical and data analysis issues related to clinical trials & regulatory submissions
- Effectively communicate and discuss complex statistical & drug development issues with R&D Leadership Team, and other Key Leaders, and influence portfolio strategy
- Be the accountable statistician for all regulatory interactions, and support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND, NDA, MAA filings.
- Identify and lead efforts to improve data infrastructure and processes to support needs of Clinical Development, and adjacent expertise areas, such as pharmacovigilance and medical affairs.
- Ensure scientific integrity & timely availability of all data management and biostatistical deliverables.
- Actively manage resources and staffing to ensure a nimble and motivated team and efficient and high quality deliverables
- Lead continued development of global data standards
- Experience building effective teams; can integrate and manage conflict.
- Effective at attracting and developing talent to build a highly effective technical function.
- Adept and motivated to improve both strategic and operational excellence; willing to “roll up his/her sleeves and do what it takes” to achieve critical program deliverables.
- Rapid and agile decision-maker who can lead the team in soliciting and analyzing multiple points of view. Can exert good judgment regarding when to elevate issues above the team level.
- Possesses effective communication skills; is an active listener and fosters a team climate of open and honest communication.
- Motivates others by creating a climate in which team members strive to do their best; invites input from others and shares ownership for team success.
- Demonstrates strong organizational/presentation skills.
- Fosters trust through strong partnership and collaboration with all team/sub-team members and leaders/stakeholders.
- Excellent interpersonal skills with particular emphasis on communication, influencing, & relationship building.
- Ph.D. in Biostatistics or Statistics with 10+ years biotechnology/pharmaceutical biostatistics experience
- Experience managing teams of Statisticians, Data Managers, and SAS Programmers
- Ability to partner and provide strategic depth in drug development area
- NDA, MAA submission experience required
- Experience across all areas of development, from FIH through filing and post-marketing across a variety of therapeutic areas desirable
- Experience with analysis of real world data desirable
- Experience interacting with U.S. and Global regulatory authorities, including NDA/BLA/MAA filings
What we offer:
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts.
- A culture inspired by our values: put patients first; think independently, be radically transparent; act nimbly; and let science speak.
- Learning and development training to help employees be the best version of themselves.
- Collaborative business environment.
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs).
- Excellent benefits package.
- Flexible PTO.
- With office locations in San Francisco, Boston, New York and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs.
- Fast-paced, data-driven, work environment with world-class R&D minds and capabilities.
- Work with the most productive groups of R&D operators in the industry.
- Partnerships with leading institutions.
- A platform for meaningful scientific contributions to shine.
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead and supported in their efforts to do so.