Senior Manager, Clinical Data Scientist

Summary

Join ML Bio Solutions, a BridgeBio company, as a Clinical Data Scientist to drive clinical data management activities, ensuring data integrity and quality for our LGMD2I clinical development program. You will collaborate with cross-functional teams, review clinical data, generate reports, and participate in data review meetings. This role requires strong analytical, communication, and organizational skills, along with experience in the biotech/pharmaceutical industry. We offer a competitive compensation and benefits package, including flexible PTO, opportunities for career advancement, and a collaborative, patient-focused environment. The ideal candidate will possess a minimum of 6 years of operational experience and knowledge of ICH GCP and Good Clinical Data Management guidelines. We are committed to diversity, equity, and inclusion.

Requirements

• Self‐motivated and proactive
• Excellent problem-solving and time management skills
• Excellent communication skills (written and verbal)
• Minimum of 6 years of operational experience in the biotech, pharmaceutical, and/or CRO setting
• Knowledge of ICH GCP and Good Clinical Data Management guidelines
• Strong working knowledge of Electronic Data Capture systems (e.g., Medidata Rave) and other databases (e.g., IVRS/IWRS, eCOA, Central Lab)
• Proficient in Microsoft Office Suite
• Experience analyzing data in SAS or other data analytics tools
• Great interpersonal skills
• Strong attention to detail
• Highly organized
• Knowledge of CDISC and SDTM standard terminology

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

Preferred Qualifications

Bachelor’s degree (or equivalent) in relevant scientific discipline

Benefits

• 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
• 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