Eidos Therapeutics, a subsidiary 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 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 San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.
Who You Are:
The Senior/Principal Clinical Programmer will perform 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. or 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. This individual 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 the final requirements and structure of study data being presented.
- Create 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
- Collaborate 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
- Assist in the management of electronic data from external data sources/vendors in partnership with the Data Management Lead; liaise with vendors as needed to facilitate electronic data transfers and/or data specification requirements
- Assist in the review and approval of required study documentation, including design specifications, user requirements, data transfer specifications, and data standards
- Generate safety surveillance and/or safety quality data review outputs and patient profiles for Drug Safety and Clinical Development clinical data review
- Provide leadership, training, guidance, and support to other department members on data review tools such as SAS
- Collaborate with clients, peers, programmers, project teams, and/or requestors to clarify and finalize data specifications; use expanded technical skills to meet evolving project needs
- Support 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).
- Support initiatives for Data Management and Clinical Programming for clinical data review bridging activities, meetings, discussions
- Possess and maintain a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
Education, Experience & Skills Requirements:
- Bachelor’s degree (or equivalent) in Science and/or Computer Systems/IT background
- Minimum 5 years of 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 develop and validate CDISC standard datasets
- Microsoft applications: Word, Excel, PowerPoint, etc.
- Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with a 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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
- Learning and development training to help employees be the best version of themselves
- Collaborative business environment
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
- Excellent benefits package
- Flexible PTO
- With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
- A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
- Work with the most productive groups of R&D operators in the industry
- Partnerships with leading institutions
- A platform for meaningful scientific contributions to shine
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.