- This position will be responsible for shaping the vision, direction, and strategic framework of the statistical programming function within the Biometrics department
- Develop departmental programming standards that align with both business needs and regulatory requirements, thereby facilitating the efficient production of high-quality deliverables
- Build a team of programmers to support ongoing clinical development and oversee outsourced programming projects
- Oversee programmers (vendors and internal) who produce CDISC-compliant derived datasets, (SDTM and ADaM) and produce validated tables, listings, and figures (TLFs) to support clinical study reports, safety update reports, publications and internal decision making
- Collaborate cross-functionally to resolve issues and ensure effective communication throughout drug development process
- Provide leadership and expertise for day-to-day statistical programming tasks in support of ongoing projects
- Ability to understand ad hoc requests from clinicians and produce accurate results quickly
- Perform vendor qualifications regarding statistical programming functions and manage CROs regarding programming issues and activities to ensure on time deliverables within budget
- Oversee and provide hands-on programming support to regulatory submission, treatment randomization, unblinding, interim analysis, and release of study top-line results for press release; manage timeline and ensure the on-time deliveries
- 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
- MS, BS/BA degree in Statistics, Mathematics, or Computer Science, or other suitable qualification with relevance to the field
- Director: 10+ years Statistical Programming exp in biotech/pharma/CRO, including 5+ years managing programmers & overseeing outsourcing
- Sr. Director: 15+ years hands-on experience, including 5+ years in management role
- Strong hands-on SAS programming skills, expertise in EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical coding dictionaries, controlled terminologies, as well as in industry standards for electronic submission of data to FDA
- A comprehensive understanding of SAS/BASE, SAS/STAT/, SAS/GRAPH and SAS macro languages
- Experience in leading statistical programming and data efforts for global regulatory submissions
- A demonstrable record of strong leadership and teamwork, and ability to work within cross-functional teams; possesses outstanding interpersonal skills, demonstrating the capability to work both independently and cooperatively within a dynamic team environment
- Proficient in managing multiple projects with a demonstrated ability to prioritize takes, anticipate challenges, pay attention to details, and execute actions effectively, is highly valuable
- Demonstrate a strong sense of accountability and ownership for assigned projects; take initiative to ensure timely and successful project delivery
- 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
- Commitment to Diversity, Equity & Inclusion
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Director/Senior Director, Statistical Programming San Francisco, CA/Hybrid - Palo Alto, CA, United States - BridgeBio Pharma
Description
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.
No matter your role at BridgeBio, successful team members are:
Education, Experience & Skills Requirements
What We Offer
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