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Director/Senior Director, Biostatistics

Employer
BridgeBio LLC
Location
Working from home
Start date
Sep 8, 2021

View more

Discipline
Science/R&D, Biostatistics
Required Education
Doctorate/PHD/MD
Position Type
Full time
About MLBio Solutions & BridgeBio Pharma

MLBio Solutions, an affiliate of BridgeBio Pharma, is a biotechnology company founded by the McColl and Lockwood families after a family member was diagnosed with the condition. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

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 the US (San Francisco, Palo Alto, Boston, New York, Raleigh), and EMEA (Zug, Switzerland) with small satellites in other parts of the country.

To learn more about our story and company culture, visit us at https://mlbiosolutions.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 therapy for a genetic neuromuscular disease. In addition, this individual may be the accountable statistician for regulatory interactions for the assigned trials and support analysis and assembly of data for various 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 neuromuscular clinical trials
  • Leverage advances in the field and, where appropriate, employ and/or develop innovative trial designs & statistical methodologies in the creation 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 an agile 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
  • No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed


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 neuromuscular and rare disease/orphan drug therapeutic areas
  • Documented experience providing statistical results through publications, posters, and/or presentations
  • NDA, MAA submission experience strongly desired
  • Experience across all areas of development, from FIH through filing and post-marketing across a variety of therapeutic areas desirable
  • Experience interacting with U.S. and Global regulatory authorities, including NDA/BLA/MAA filings


What We Offer:
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.

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