Senior Manager, Clinical Data Scientist

Summary

Join ML Bio Solutions, an affiliate of BridgeBio Pharma, as a Manager/Sr. Manager, Clinical Data Scientist to contribute to the development of BBP-418, a potential first-oral treatment for LGMD2I. Drive internal and outsourced Clinical Data Management activities, ensuring data integrity and quality for clinical research studies. Collaborate with cross-functional teams and external vendors, reviewing clinical data and generating reports. Maintain data issue tracking and lead data review activities. This U.S.-based remote role requires occasional visits to the San Francisco office. The ideal candidate possesses strong analytical, communication, and organizational skills, along with extensive experience in clinical data management within the biotech/pharmaceutical industry.

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 preferred

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability
• Subsidized lunch via Forkable on days worked from our office
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities