Manager/Senior Manager, Statistical Programming

About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing CLTX-305 (encaleret), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (a genetic cause of hypoparathyroidism due to gain-of-function mutations in CaSR). Encaleret is currently being evaluated in a Phase 2 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.

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 https://calcilytix.com/ |https://bridgebio.com

Who You Are

The Manager or Senior Manager of Statistical Programming will lead the statistical programming activities and programming submission-related activities. In addition to working as a hands-on programmer for various internal requests, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions.

The candidate may work 100% remotely for this position or work onsite or hybrid with the team in our San Francisco office.

Responsibilities

• Lead statistical programming activities, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency
• Review CRO deliverables and perform acceptance checks and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards  
• Review and/or execute statistical programming deliverables related to study monitoring, clinical study reports, data integrations, and regulatory query responses
• Perform hands-on SAS programming to generate TFLs to support ad hoc requests and decision making
• 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, to support 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 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

• MS in Statistics, Computer Science, or a related field with 5+ years of relevant experience, or BS in Statistics, Computer Science, or a related field with 7+ years of relevant experience
• Two years of experience as a lead statistical programmer is desired
• Good knowledge of CDISC standards and Pinnacle 21 validator
• Experience in NDA/BLA submission is a plus
• Experience in CRO oversight preferred
• Experience with statistical programming methods and processes in clinical development
• Demonstrated proficiency and expertise in SAS programming for data analysis in clinical trials
• Commitment to quality and timeline

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
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We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.