Manager/Sr. Manager, Clinical Data Scientist

About MLBio Solutions & BridgeBio Pharma

ML Bio Solutions (ML Bio), a BridgeBio company, is a biotechnology company founded in 2018, yet the company’s founders have been dedicated to finding a cure for Limb girdle muscular dystrophy type 2I/R9 FKRP-related (LGMD2I/LGMDR9) for close to twenty years. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

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 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 https://mlbiosolutions.com/ | https://bridgebio.com

Who You Are

The Clinical Data Scientist must be able analyze data, drive data review activities and engage different functional groups to ensure data integrity, quality, and completeness. The employee should have strong interpersonal communication and organizational skills and must be able to work proactively with limited oversight. The Clinical Data Scientist is expected to conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines, as well as all ML Bio policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.  

Responsibilities

• Drive internal and outsourced Clinical Data Management activities in support of clinical research studies
• Contribute to and ensure quality of Data Management study documentation by CROs and other vendors, including CRFs, completion guidelines, database specifications, edit checks, data review plans, data management plans, data transfer specifications, SAE reconciliation plans, and external vendor (i.e. central lab) data reconciliation plans
• Develop a functional understanding of the LGMD2i clinical development program, study protocols and statistical analysis plans related to study endpoints and data management activities
• Support communication and coordination between the biometrics functions (CDM, Biostats, Stat Programming) and stakeholders from other functions (i.e. Clinical Operations, Clinical Development, Regulatory, Program Management)
• Review clinical data listings, patient profiles, and summaries to ensure data collection proceeds consistently with the protocol
• Generate data metrics, reports and summaries to identify and communicate data quality issues and trends to the study team
• Maintain tracking of known data issues, risks and mitigations
• Represent the Clinical Data Management/Scientist function in meetings with relevant cross‐functional teams and external vendors
• Liaise with specialty laboratories and other external data providers as needed to ensure data transfers are in accordance with data transfer specifications and plans
• Lead cross‐functional data review activities/meetings; manage the collection of data issues, reporting of findings, and communication of post‐review status
• Communicate with cross functional teams to drive data cleaning initiatives/cuts, interim and final database locks
• Participate in the development of new processes or revision of existing processes
• Contribute to the development of training materials(EDC System, CRFs, Completion Guidelines) for Site, CRO, and Internal staff as needed
• Meet study timelines with a high degree of quality
• Other duties as assigned

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<