Orfan Biotech, a subsidiary of BridgeBio Services, was founded in 2017 to develop new therapies for diseases of hyperoxaluria. Based on the initial discoveries of its scientific founder, Dr. Eduardo Salido, at the University of La Laguna in the Canary Islands, Orfan Biotech has quickly developed new compounds to treat primary hyperoxaluria and related conditions. Currently, the company focuses on the genetic and rare primary disease hyperoxaluria (PH1), a disease for which the only cure is a double kidney and liver transplant.
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including... genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country.
To learn more, visit us at https://www.orfanbiotech.com/ | https://bridgebio.com
Who You Are:
Reporting to the Chief Analytics Officer of BridgeBio, this individual may be called upon to partner with other functional areas to provide statistical input on the design, execution, data analysis, and interpretation of clinical trials for a small molecule inhibitor of glycolate oxidase. In addition, this individual may be the accountable statistician for regulatory interactions for the assigned trials, and support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND, NDA, MAA, and ROW filings.
Responsibilities:
- Strategically partner with Clinical Development, Regulatory, and Clinical Operations expertise areas to provide statistical input into the design, execution, data analysis, and interpretation of cardio-renal clinical trials
- Leverage advances in the field and, where appropriate, employ and/or develop innovative trial designs & statistical methodologies in the design of efficient and effective clinical trials
- Lead data analysis and interpretation for CSRs, marketing applications, manuscripts, abstracts, and other publications
- 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 the R&D Leadership Team, and other Key Leaders, and influence portfolio strategy
- Be the accountable statistician for regulatory interactions for assigned trials
- Support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND, NDA, MAA, and ROW 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
- Adept and motivated to improve both strategic and operational excellence; willing to “roll up their sleeves and do what it takes” to achieve critical program deliverables
- Can exert good judgment regarding when to elevate issues above the team level
- Possesses excellent communication skills; is an active listener and fosters a team climate of open and honest communication
- Invites input from others and shares ownership for team success
- Remain current with FDA and international regulatory guidance relevant to cardio-renal diseases and orphan drug development
Education, Experience & Skills Requirements:
- Ph.D. in Biostatistics or Statistics or related fields with 10+ years of biotechnology/pharmaceutical biostatistics experience
- Experience managing teams of Statisticians and SAS Programmers
- Ability to partner and provide strategic depth in cardio-renal diseases and orphan drug therapeutic areas
- Documented experience providing statistical results through publications, posters, and/or presentations
- NDA, MAA submission experience strongly desired
- Specialized training and experience with adaptive designs, Bayesian hierarchical models, platform and/or basket trials, design of experiments, group sequential designs, pharmacoepidemiology, statistical de-identification, multiple testing, or statistical sampling would be advantageous
- 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 and companion diagnostic bridging study 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; every minute counts, and let the 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
- A 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
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees
