Clinical Data Scientist

Location:  San Rafael, California Category: BioMetrics

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Role Summary

As part of the Data Management group, an integral delivery unit within the Worldwide Research & Development (WWRD) organization, the Clinical Data Scientist is responsible for timely and high quality data management deliverables supporting the BioMarin portfolio. The Clinical Data Scientist designs, develops, and maintains key data management deliverables used to capture, validate, monitor, and ensure the integrity of clinical data, oversees application of standards, data validation and query management, and is accountable for quality study data set release and consistency in asset/submission data.

Role Responsibilities

Clinical Data Scientist

  • Serve as Clinical Data Scientist for one or more clinical trials assuming responsibility for all CDM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
  • Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
  • Serve as a technical resource to the study teams for CDM standards, tools, data provisioning, and reporting
  • Partners with Research/Business Units and any external CDM service provider to deliver high quality data management for all studies as assigned.
  • Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).
  • Ensure work carried out by DM providers is in accordance with applicable SOPs and working practices.
  • Ensure the required study-specific CDM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
  • Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.

Qualifications

  • Proficient experience using Medidata Rave software
  • Working experience applying CDISC CDASH standards
  • Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting
  • Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
  • Strong Project and Risk Management
  • CRO and vendor oversight experience preferred
  • Strong verbal and written communication skills
  • Consistent, detail oriented, communicative, dedicated to do a job well done
  • Minimum 5 years Data Management experience required
  • Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
  • Experience using data visualization tools (e.g. Spotfire, jReview)
  • Familiarity with MedDRA/WHO-Drug
  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
  • Bachelor’s degree required.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.