Associate Director/Director, Statistical Programming

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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. 

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

Who You Are:

The Associate Director/Director, Statistical Programming, will lead the statistical programming activities for multiple studies and the programming submission-related activities. In addition to work as a hands-on programmer for various internal requests, this individual will also need to manage, guide, and validate the CRO programming team and work collaboratively with internal and external teams in results reporting and regulatory submissions.

Responsibilities:

• Lead and manage statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency
• Manage CRO to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards by reviewing CRO deliverables and perform acceptance check and validation
• Manage, review, and/or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations, and regulatory query responses, covering multiple studies
• Collaborate with external alliances for all programming-related activities; ensure successful and effective coordination and communications
• Perform hands-on SAS programming to generate TFLs to support ad hoc requests and decision making
• Represent the statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines
• Review data management documents (such as CRF specification, data transfer agreements, data management plan, annotated CRF), SDTM specification, ADaM specification, Statistical Analysis Plan, and TFL shells to provide statistical programming feedback; perform other tasks as needed, including UAT of clinical databases, in support to the data management and operation teams
• Identify, develop and maintain statistical programming standards, processes, and SOPs
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:

• MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience, or BS in Statistics, Computer Science, or a related field with 12+ years of relevant experience
• Minimum of 5 years of experience as a lead statistical programmer
• Extensive knowledge of CDISC standards and Pinnacle 21 validator
• Experience in NDA/BLA submission
• Experience of CRO oversight preferred
• Advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
• Experience in clinical development statistical programming methods and processes in industry setting required
• Demonstrated proficiency and expertise in SAS programming for data analysis in clinical trials
• Ability to manage multiple projects in a fast-paced environment

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.