Manager/Sr. Manager, Clinical Data Scientist

Agrisano Unternehmungen; United States; Remote; USD 145,000 - 190,000; Full time

Job summary

An innovative biotechnology company is seeking a Clinical Data Scientist to drive data integrity and quality in clinical research. This role involves collaborating with cross-functional teams, managing data review activities, and ensuring compliance with regulatory guidelines. The ideal candidate will have a strong background in data management, excellent communication skills, and a proactive approach to problem-solving. Join a dynamic team that values scientific excellence and is committed to transforming patient care through groundbreaking research. This position offers a flexible remote work environment and opportunities for rapid career advancement.

Benefits

Flexible PTO

Access to learning and development resources

Robust compensation & benefits package

Commitment to Diversity, Equity & Inclusion

Rapid career advancement for strong performers

Collaborative, fast-paced environment

Qualifications

• Minimum of 6 years of experience in biotech, pharma, or CRO settings.
• Knowledge of ICH GCP and Good Clinical Data Management guidelines.

Responsibilities

• Drive Clinical Data Management activities for clinical research studies.
• Review clinical data to ensure consistency with protocols.
• Generate metrics and reports to identify data quality issues.

Skills

Problem-solving

Time management

Communication skills

Interpersonal skills

Attention to detail

Organizational skills

Education

Bachelor’s degree in relevant scientific discipline

Tools

SAS

Electronic Data Capture systems

Microsoft Office Suite

Job description

Manager/Sr. Manager, Clinical Data Scientist

Remote - United States

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 for genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 30+ drug development programs across 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 ML Bio Solutions | BridgeBio

The Clinical Data Scientist must 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 work proactively with limited oversight. The Clinical Data Scientist is expected to conduct work activities in compliance with all relevant laws, regulations, and regulatory guidelines, as well as all ML Bio policies and procedures.

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 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 as needed
• 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 as needed
• Meet study timelines with a high degree of quality
• Other duties as assigned

Education, Experience & Skills 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
• 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
• Bachelor’s degree (or equivalent) in relevant scientific discipline preferred

What We Offer

• Patient Days, where we hear directly from individuals living with the conditions we impact
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• A decentralized model that enables our program teams to focus on advancing science and helping patients
• A collaborative, fast-paced, data-driven environment
• Access to learning and development resources
• Robust and market-competitive compensation & benefits package
• Flexible PTO
• Rapid career advancement for strong performers
• Commitment to Diversity, Equity & Inclusion

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. The anticipated salary range for this role is $145,000 - $190,000 USD.

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