Associate Director/Director, Biostatistics

Full-TimeBridgeBioSan Francisco, CABiostatistics & Data Management

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About BridgeBio Pharma, Calcilytix, & Cantero

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing CLTX-305 (encaleret), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (a genetic cause of hypoparathyroidism due to gain-of-function mutations in CaSR). Encaleret is currently being evaluated in Phase 2 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.

Cantero Therapeutics, formerly known as Orfan Biotech, is an affiliate of BridgeBio Pharma 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.

To learn more about our story and company culture, visit us at https://calcilytix.com/ | https://bridgebio.com

Who You Are:

The Associate Director/Director of Biostatistics is responsible for statistical activities supporting clinical trials, including contributing to study designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This role will interact with internal and external cross-functional study teams and manage contract research organization (CRO) programmers and statisticians in preparing analysis datasets and performing statistical analyses. The Associate Director/Director of Biostatistics will also support the analysis and assembly of data for various regulatory activities, including the preparation of IND, NDA, MAA, and ROW filings.
Responsibilities:
  • Provide strategies for clinical study design, endpoint selection, sample size calculation, statistical analysis plan, and data interpretation in collaboration with study team members
  • Evaluate and implement innovative designs and novel statistical methodologies as appropriate for efficient and effective clinical studies
  • Act as the primary contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors; work collaboratively with CROs, vendors, clinical development, regulatory, clinical operation, and project management to meet project deliverables and timelines for statistical data analysis and reporting; ensure biostatistics deliverables are accurate
  • Prepare and/or review in detail the statistical analysis plan (SAP), including development of well-presented mock-up displays for tables, listings, and figures (TLFs), conduct data analyses, and oversee the preparation of all TLFs (including review of work by programmers), as well as the preparation of the clinical study report
  • Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications
  • Ensure accurate, statistically valid deliverables are included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
  • Address questions from regulatory agencies; support analysis and assembly of data for a variety of regulatory activities, including the preparation of IND, NDA, MAA, and ROW filings

  • 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 Statistics or Biostatistics with 7+ years of biotechnology/ pharmaceutical biostatistics experience, or MS in Statistics or Biostatistics with 10+ years of biotechnology/ pharmaceutical biostatistics experience
  • Extensive knowledge of statistical methodology and its application in clinical trial design and data analyses
  • Excellent programming skills in SAS and/or R
  • Experience managing CROs, providing oversight to outsourced work
  • NDA/BLA/MAA submission experience is highly desirable
  • Specialized training and experience with adaptive designs, Bayesian hierarchical models, platform and/or basket trials, design of experiments, sequential group designs, pharmacoepidemiology, statistical de-identification, multiple testing, or statistical sampling would be advantageous
  • Excellent oral and written communication skills
  • Solid knowledge in drug development across phases and updated understanding of health authority guidelines
  • Demonstrated effectiveness in working with multi-functional team members to deliver common goals
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

  • #Li-Remote
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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Associate Director/Director, Biostatistics

Full-TimeBridgeBioSan Francisco, CABiostatistics & Data Management

Apply Now