Manager/Sr. Manager, Clinical Data Scientist

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

ML Bio Solutions (ML Bio), an affiliate within BridgeBio Pharma, was 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.

What You'll Do

The Manager/Sr. Manager, 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 Manager/Sr. Manager, 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 

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office. 

Who You Are

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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial 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

Health & Wellbeing:

• 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

Skill Development & Career Paths:

• 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