What are the responsibilities and job description for the Manager/Sr. Manager, Clinical Data Scientist BridgeBio $145k - $190k/year ⋅ Interested Not Inte[...] position at Savvy, Inc.?
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, dedicated to finding a cure for Limb girdle muscular dystrophy type 2I / R9 FKRP-related (LGMD2I / LGMDR9). 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. 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, and Raleigh, with international offices in Montreal, Canada, and Zurich, Switzerland.
To learn more about our story and company culture, visit us at MLBio Solutions | BridgeBio
Who You Are
The Clinical Data Scientist must be able to 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
- Develop a functional understanding of the LGMD2i clinical development program, study protocols and statistical analysis plans
- Support communication and coordination between the biometrics functions and stakeholders from other functions
- 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
- 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
- Lead cross‐functional data review activities / meetings
- Communicate with cross functional teams to drive data cleaning initiatives
- Participate in the development of new processes or revision of existing processes
- Contribute to the development of training materials for Site, CRO, and Internal staff
- Meet study timelines with a high degree of quality
- Other duties as assigned
Who We Are
No matter your role at BridgeBio, successful team members are :
Education, Experience & Skills Requirements
What We Offer
Salary
145,000—$190,000 USD
Skills
Biotechnology Research, Analyst, and Information Technology
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Salary : $145,000 - $190,000
