BD (Becton, Dickinson and Company) Clinical Data Scientist in Murray Hill, New Jersey
Job ID: 2018-11820
Career Level: experienced
Division: BDI Corporate
Location: Murray Hill,New Jersey,United States
Summary of Position with General Responsibilities:
The Clinical Data Scientist (CDS) draws on their extensive clinical and scientific knowledge to ensure relevant data are collected on clinical studies and that the data collected are clinically plausible. The CDS will perform a detailed review of clinical study protocols, ensure the data collection requirements are clear and identify the critical data elements required to be collected in support of the study endpoints. The CDS will interact with division personnel as well as perform their own independent research to gain a thorough understanding of disease states, procedural details and therapeutic areas. The CDS will interact with Data Management and members of the Clinical Affairs team to develop high quality and concise CRFs targeted to evaluate the study endpoints. He/She will provide input into the development of edit checks that examine medically meaningful correlations among the various data points. The CDS will routinely review clinical data to ensure clinical accuracy and proactively identify any trends that may adversely impact data quality. The CDS will lead cross functional data quality review meetings to examine the data. The CDS will be responsible for leading the development of reports that facilitate medical monitor and/or data monitoring committee review of the safety data as well as perform MedDRA coding of adverse events. The CDS will provide input into the Statistical Analysis Plan (SAP) and actively participate in Dry Run review meetings conducted by Statistics. He/She serves as a resource for Data Management to facilitate an understanding of the scientific aspects of the clinical study.
Essential job Functions:
Perform detailed examination and provide feedback on study protocols to ensure the data collection requirements are clear and supportive of the study endpoints.
Design high quality CRFs in collaboration with a cross functional team that are clinically meaningfully, accurately reflect the data collection requirements identified in the study protocol, and consistent with internal standards.
Define edit check specifications and data review listings that examine correlations among the various data points and ensure the data is clinically meaningful.
Review data on a continuous basis to ensure clinical accuracy and proactively identify trends that may adversely impact data quality.
Lead cross functional data quality review meetings to ensure awareness of the data and any relevant trends.
Drive development of reports to facilitate medical monitor and/or data monitoring committee review of safety data.
Provide input into the SAP and participate in Dry Run review activities.
Performs MedDRA Coding of adverse events.
Serves as a resource for Data Management to facilitate an understanding of the scientific aspects of the clinical study.
Participates in User Acceptance Testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
Maintains knowledge of current regulations and technologies related to the data management function.
Provides mentoring/coaching of new hires and/or junior associates.
Maintains accurate and complete study records.
BS or MS degree in scientific discipline
Minimum 2 years experience working in the pharmaceutical/medical device industry
Minimum 5 years working in a hands on clinical environment (cath lab, core lab, nursing)
Experience with MS Word, Excel and Powerpoint.
Additional Desirable Qualifications Skills and Knowledge:
Effective communication skills both verbal and written.
Ability to work independently with minimal supervision and accountable for managing multiple studies concurrently.
Demonstrates leadership abilities.
Understands clinical research process and regulatory requirements.
Able to acquire and apply new technical skills.
Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships.
Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project.
Follows through on all tasks and ensures quality results.
Multi-disciplinary knowledge across functional areas.
Experience with relational databases used in Data Management or Safety.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status