Randstad Clinical Operations in North Chicago, Illinois
location:North Chicago, IL
salary:$30.14 - $35.46 per hour
date posted:Wednesday, September 13, 2017
Job Title: Clinical Statistician I - B
Responsible for surveillance activities for compounds in clinical development and for postmarketed products, including signal detection through review of data from multiple
sources, including clinical trial and PV databases, and the literature.
Maintains the strategy for surveillance activities and recommends revisions to the monitoring plan, as needed.
Key contributor to signal assessment and ad hoc regulatory safety requests by analyzing data from the clinical trial and global safety database as well as literature and utilizing clinical judgement to determine the impact of the safety issue on the product's benefit/risk profile.
Communicates findings of surveillance activities and safety assessments to a variety of audiences, including the Product Safety Team (PST) and management, to inform on necessary risk minimization activities, including label changes.
Works closely with the PST Lead physicians to develop strategies and approaches for routine and ad hoc safety deliverables.
Contributes to the strategy, authoring and review of global safety reports (PSURs/PBRERs, ACOs, DSURs, PADERs in accordance with regulatory requirements and standard operating procedures.
Supports various process improvement initiatives for both Safety Data Sciences (including qualitative and quantitative approaches for signal detection) and PPS overall.
Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports as well as the Company Core Data Sheet and Risk Management Plan
Contributes to safety activities between PST and internal and external partners, represents Safety (Safety Data Sciences) in internal and external cross-functional settings
Health science degree (e.g., PharmD, RN)
2-3 years of related work experience. Preference given to applicants with experience
in the pharmaceutical industry.
Understanding of the drug development lifecycle, from clinical development through post-approval.
Ability to utilize clinical judgement and interpret medical safety data to assess safety issues within the context of the product's benefit/risk profile
Excellent oral and written communication skills with the ability to manage multiple projects simultaneously
Experience working in a cross-functional environment
Experience manipulating/understanding large and complex data sets
Experience integrating data from multiple sources to answer specific questions
Basic Project Management skills and Microsoft WORD and EXCEL skills
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance