Senior Analyst I, Clinical Trial Safety

Location: Durham, NC

Hybrid Policy: 3 Days onsite/week

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Job Description:

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

Typical Accountabilities:

• 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.

Education, Qualifications, Skills and Experience:

Essential:

• 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

Desired:

• 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

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

#LI-Hybrid

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.