About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia.
Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications.
With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
Our business is inspired by our values:
PUT PATIENTS FIRSTEVERY MINUTE COUNTSTHINK INDEPENDENTLYBE RADICALLY TRANSPARENTFGFR=fibroblast growth factor receptor. 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, Raleigh, and 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.
Associate Director, Biostatistics is responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.
Successful candidates will also interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.
ResponsibilitiesProvide statistical input to study design, protocol development, sample size calculation, Case Report Form, Results Interpretation, clinical study report, and addressing questions from regulatory agencies.
Collaborating with CRO, develop and maintain SAPs, including the derived variables, the templates of statistical tables, figures, and listings, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publicationsProvides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high-quality dataWorks collaboratively with Statistical Programmers, Biostatisticians, Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelinesCRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide CRO biostatisticians and statistical programmers.
Ensures deliverables are accurate and delivered according to the timelinesGlobal Health Authority Interaction: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document.
May participate in meetings or teleconferences with Health AuthoritiesCoordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities; attend team meetingsNo matter your role at BridgeBio, successful team members are: Patient Champions, who put patients first and uphold strict ethical standardsEntrepreneurial Operators, who drive toward practical solutions and have an ownership mindsetTruth Seekers, who are detailed, rational, and humble problem solversIndividuals Who Inspire Excellence in themselves and those around themHigh-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills RequirementsPh.
D. in statistics or biostatistics and 5+ years relevant experience in the pharmaceutical/biotechnology industry or MS in Biostatistics or Statistics and 8+ years relevant experience in the pharmaceutical/biotechnology industryProven knowledge and expertise in statistics and its applications to clinical trialsTeam player with the ability to work successfully across functionsDemonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concepts into layman's termsDemonstrated leadership skillsProficiency with statistical programming in SAS and/or RKnowledgeable in CDISC standards, including SDTM, ADaMFamiliar with ICH guidelines, FDA, and other regulatory authority guidancePreferably NDA experience, including eCTD submissionWhat We OfferPatient 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 effortsA culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speakAn unyielding commitment to always putting patients first.
Learn more about how we do thishereA 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 scienceA place where you own the vision – both for your program and your own career pathA collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our gameAccess to learning and development resources to help you get in the best professional shape of your lifeRobust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)Flexible PTORapid career advancement for strong performersPotential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over timeCommitment to Diversity, Equity & InclusionAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
Below is the anticipated salary range for candidates for this role who will work in California.
The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.
BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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