Sr./Principal Clinical Programmer

1 month ago

San Francisco CA, United States BridgeBio Pharma, Inc. Full time

About BridgeBio

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 20+ 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 aim to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at

Who You Are

The Sr./Principal Clinical Programmer will be responsible for performing SAS programming to support data management/clinical development operational activities. This includes developing customized, programmed data listings and data reports/visualizations to support clinical data review and process efficiency. The Sr./Principal Clinical Programmer will manage incoming clinical data from our clinical vendors and ensure data is received and processed according to data transfer specifications and study requirements and will also lead clinical programming activities across one or more studies for the DM/Development Operations and Clinical Development functional areas and liaise with our biostatisticians to understand final requirements and structure of study data being presented.

Responsibilities

* Creates standard and/or custom programs/reports using data analytics tools such as SAS, Tableau, or other data visualization tools to support data oversight and review by data managers or other data reviewers

* Collaborates with Clinical Operations, Data Management, Clinical Development, Drug Safety, Statistical Programming, and Biostatistics to develop standard and custom data reports for quality data oversight / clinical data review

* Assists in the management of electronic data from external data sources/vendors in partnership with the Data Management Lead

* Liaises with vendors as needed to facilitate electronic data transfers and/or data specification requirements

* Assists in review and approval of required study documentation, including design specifications, user requirements, data transfer specifications and data standards

* Generates safety surveillance and/or safety quality data review outputs and patient profiles for Drug Safety and Clinical Development clinical data review

* Provides leadership, training, guidance, and support to other department members on data review tools such as SAS

* Collaborates with clients, peers, programmers, project teams, and/or requestors to clarify and finalize data specifications; uses expanded technical skills to meet evolving project needs

* Supports the development, delivery and maintenance of clinical data review standards, tools and systems, across various data sources (e.g., clinical data, safety and operational data)

* Supports initiatives for Data Management and Clinical Programming for clinical data review bridging activities, meetings, discussions

* Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, selftraining, attending training classes, attending professional meetings, etc.

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 toward 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

* Bachelor's degree (or equivalent) in Science and/or Computer Systems/IT background

* Minimum 5 years experience in a pharmaceutical/biotech setting

* Advanced technical expertise in databases, EDC platforms, data imports/integrations

* Advanced programming and analytical skills using BASE/SAS, SAS/STAT, SAS MACROS

* Data Visualization tools (like Tableau, Spotfire) and Python programming language experience a plus

* Ability to work independently to create standard datasets, program edit checks and produce quality data review outputs

* Demonstrated understanding of CDISC and SDTM requirements and implementation guidelines, able to create and validate CDISC standard datasets

* Windows applications: Word, Excel, PowerPoint, etc.

* Good project management skills, CRO oversight skills, professional attitude, selfimprovement mentality with positive attitude

* Good written and oral presentation skills and ability to communicate effectively to other programmers and non-technical colleagues

* Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic 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

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