Senior Analyst I, Clinical Trial Safety

AstraZeneca•Durham, NC

16d•Hybrid

About The Position

The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of medical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and clinical/project scientists to interpret safety data efficiently. The Senior Analyst I, Clinical Trial Safety is responsible for tools set-up, scripting, and data analysis tasks for the Clinical Trial Safety. The Senior Analyst I works closely with all level Analysts & Scientists, Clinical Trial Safety to ensure safety data deliverables are executed per pre-defined plans and up to quality and timelines. The Senior Analyst I is adept at utilizing the Center’s Data Review tools of choice and should possess programming experience

Requirements

Bachelor degree in related discipline
Minimum one year of experience working on clinical studies in the Biotech/Pharma/CRO industry or equivalent
Proven organizational and analytical skills
Understanding of the clinical study and drug development process
Knowledge of ICH/GCP Guidelines
Knowledge of SAE reporting requirements
Proven ability to prioritize and manage multiple tasks with conflicting deadlines
Ability to work independently, as well as in a team environment
Independently designing and planning own work
Managing change and uncertainty for self
Advanced computer skills (Microsoft Outlook, Excel and Microsoft Power Platform)
Excellent knowledge of spoken and written English
Exhibit of AZ Values and Behaviours

Nice To Haves

Relevant industry or health care experience
Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas
Good understanding of clinical data flow
Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
Programming experience in data analysis and/or data mining set-up (e.g. Python, R, SAS)
Experience using data review tools such as JReview, JMP Clinical, or Spotfire
Statistic knowledge

Responsibilities

Ensure the Data Review tool is fit for purpose through set-up, maintenance and close-out of study according to agreed Best Practice procedures – to allow for handling of safety data and review for medical completeness and medical accuracy
Generate high quality Clinical/Safety Data Review reports that are aligned for TRISARC members and the Global Therapeutic Areas
Work with data outputs (i.e. generate reports, macros/scripts) from multiple sources such as the clinical database, external labs, ECG providers, and other safety vendors as appropriate.
Generate summary reports,
Analyze and visualize clinical data from different sources including but not limited to eCRF, external lab, clinical databases.
Take on ad-hoc tasks as assigned by the TRISARC Leadership team members
Provide input into non-drug project work including training activities, continuous improvement, and development of procedures as needed
Work closely with IT and R&D Information functions to align on tool maintenance and tool improvement; provide customer feedback from the end user (TRISARC Safety Specialists, Study Physicians, Clinical Scientists)
Expert on data analysis and visualization
Supports development of data review tool applicable for TRISARC.