Detail

Salary
negotiable
Location
Gaithersburg, MD, USA
Posted by: Astra Zeneca
15 Oct
79 Views
14 Dec expires

Senior Safety Analyst

Gaithersburg, MD, USA
Job Description

With expertise in statistical analysis, visualization and presentation of safety data within a variety of data sources/databases, the Senior Safety Analyst supports customers (Patient Safety and other staff engaged in the safety surveillance of marketed products and products in development) with advice on the appliction of appropriate analytic and visulisation methods and the interpretation of safety analysis outputs.  . The role holder contributes to the formulation of Surveillance Data & Analytics Group strategic goals and is responsible for the implementation, planning and execution of relevant components of strategic initiatives. The role holder proactively drives innovative approaches to safety analytics to advance the goals of Safety Sciences and will proactively and visibly propagate knowledge across relevant areas of the organisation. It is expected the role holder will collaborate both internally and externally in pursuit of excellence within their field. The role will collaborate very closely with customer teams, relevant leaders within Patient Safety Sciences & Risk Management Center of Excellence and wider enabling roles in the business, to ensure optimal delivery of safety-oriented statistical and analytic services.

 

Typical Accountabilities

  • Delivers global subject matter expertise in defined areas of safety analytics and statistics. Working in close collaboration with Patient Safety Centre of Excellence customer groups and wider stakeholders, including those in senior roles, to plan and provide strategic-enabling support and/or routine service delivery, as required.
  • Advises relevant customer groups on appropriate approaches and strategies to address statistical and safety analytic requirements, ensuring development and awareness of good practices and methodologies where appropriate.
  • Able to leverage in-depth skills & knowledge to support modelling, analysis, reporting and visualization of safety data from various sources, as appropriate.
  • Ensures that relevant standards and quality levels are defined; ensures that all work is carried out with regards to AstraZeneca standards and external regulations
  • Communicates relevant approaches and findings effectively with customer and stakeholder teams, to confirm understanding and validate that underlying scientific and business questions are appropriately addressed.
  • Coaches colleagues within relevant customer or peer groups, to support ongoing best practice and skills development (e.g. in relation to the use of relevant tools and analysis techniques).
  • Supports new innovations, projects and capability developments that enable the delivery of high quality, enabling analytic services for Patient Safety TA customers and other stakeholders.
  • Identifies opportunities to lead change in applicable areas of expertise through innovative and continuous improvement aligned with best practice across the industry including through participation in external collaborations and consortia.
  • Collaborates closely across the global CMO organisation, with stakeholders, IS vendors, and other experts involved in the design, development and delivery analytic solutions, or related business deliverables such as policies, procedures, processes and guidance.  Takes advantage of opportunities to co-develop analytic services with collaborative partners to address common cross-functional business needs.
  • Supports the overall improvement of enabling activities relating to safety analytics, including troubleshooting problems & developing solutions.  Responsible for ensuring that user support arrangements are defined as required.
Job ID Reference
1413
Desired Skills & Experience

Essential

 

  • MS or PhD in a Statistics or Epidemiology
  • Good understanding of relevant domains in the Data and Information Sciences
  • Proven technical competence, with hands-on experience, in identifying and delivering statistical and analytic solutions in complex business settings.
  • Knowledge of relevant safety data sources, including spontaneous, clinical study and real word, analytic tools and statistical packages (SAS, R).
  • Able to work with a high degree of autonomy.  Self-sufficient in terms of statistical programming.
  • A sound understanding of clinical safety, or related pharmaceutical industry experience, preferably with extensive involvement in the successful design, delivery or deployment of statistical analyses to address scientific safety-related requirements.
  • Broad knowledge of the analytic methods and tools required to support drug development, including a comprehensive understanding of clinical trials, regulatory safety requirements, pharmacovigilance practices, epidemiology practices, and safety project team activities.
  • Experience in safety signal management and/or the exploitation of clinical study safety data to define the safety profile of a products used in clinical settings.
  • Able to identify opportunities to lead change through innovation – seeking continuous improvement based on strong awareness of external competitive practice. 

 

Desirable

  •  MS or PhD in a Life Science, Computer Science or Information Science preferred
  • Experience of coordinating the delivery of relevant informatics services to support of safety-related activities in the context of clinical bio-pharmaceutical development.
  • Ability to articulate complex safety-related business needs in the context of IS systems design, architecture and development.
  • Experience of a wide array of systems and platforms,  databases and/or the use of semantic technologies to query data.
  • Experience in integrating information across multiple domains
  • Business awareness of wider IS developments within AZ or the pharmaceutical industry, particularly in relation to the design and deployment of data sources, analytical tools, informatics solutions and systems.
  • Experience across multiple therapeutic or business areas, or in working in safety-related roles within other biopharmaceutical, regulatory, or health organizations.
  • Key capabilities commensurate with the Global Career Level of the role (e.g. Leadership Capabilities)
  • Excellent interpersonal skills to influence / shape their particular area of expertise, along with the ability to understand multiple, complex business needs and identify ways in which existing or newly designed solutions could address these in an effective and efficient manner.
  • Experience in working across different geographic locations, organisations, and cultures to drive vendor and customer relationship management.
Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Gaithersburg, MD, USA