Eli Lilly and Company

Associate-Data Systems Analyst

Location
Indianapolis, IN, United States
Posted
Jun 13, 2019
Ref
49505
Required Education
Bachelors Degree
Position Type
Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Responsibilities

Is Analytics your cup of tea? Global Patient Safety (GPS) Organization at Lilly is looking for Data Systems Analyst. If you are passionate about getting involved in data analysis, management, reporting or tool development, you might be a phenomenal fit for our need. You will have the following responsibilities in this role:

  • Support reporting and analysis of pharmacovigilance (PV) data for GPS and business areas external to GPS within Lilly
  • Develop analytic tools to support PV activities and manage multiple data sources to meet business needs and incorporate automation when possible


This role provides you an opportunity to work cross functionally with diverse teams. Major areas of focus will be in:
1. Global Patient Safety Team Support

  • Develop high-level expertise on global issues around regulatory practices as they relate to GPS
  • Act as subject matter expert in the understanding of selected GPS business practices including standard operating procedures
  • Develop and update GPS training tools/programs as it relates to reporting, data management and programming and validation
  • Provide reporting and programming support to Case Management, Surveillance, Pharmacoepidemiology & other business areas within GPS, Therapeutic Areas and Affiliates in GPS
  • Incorporate various data sources in evaluating safety concerns
  • Provide programming, and data management support to DSA Pharmacoepidemiology to understand the nature and burden of illness of diseases/conditions for new products to treat or to prevent
  • Support analysis used to characterize disease trends, frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors and treatments


2. Support Portfolio Development Planning and Activities

 

  • Provide programming and data management expertise to support new product launches and existing marketed products; including support for periodics such as patient exposure estimates, etc
  • Provide reporting, coding and validation support for activities related to portfolio development, collaborate with internal business partners and with external partners such as CROs, and vendors for product related activities


3. Collaboration with Internal and External Customers

 

 

  • Communicate effectively with internal contacts from the Affiliate offices, legal and other customer groups
  • Collaborate with Program/Product Teams and Regulatory Scientists on issues of product safety, request for safety information and in preparation of responses to requests posed by regulatory authorities


4. Strategic Development of Analytic Tools

 

 

  • Develop analytical tools to assess safety across clinical studies (in real time) and for post-marketing surveillance
  • Support the investigation for the potential use of data mining tools for clinical trial data and spontaneous data
  • Partner on the development of new standardized analytic methods for selected regulatory safety documents/submissions (e.g., PSUR, ISS, product labels)


5. Quality and Compliance

 

 

  • To have an understanding of the role and responsibilities of the EU Qualified Person and ensure support to fulfill his/her legal responsibilities

49505BR

Basic Qualifications

 

 

  • A bachelor's degree
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

 


Additional Skills/Preferences

 

 

 

  • Competent in the independent analysis of data from clinical and epidemiology studies
  • Excellent computer skills; extensive programming knowledge of SAS, SPSS, Epic Info, and/or equivalent statistical software package
  • Have strong oral and written communication skills, strong interpersonal and leadership skills such as initiative and influence, and able to work independently and as a team member to resolve a variety of drug safety issues
  • High-level knowledge of global regulations with respect to adverse event reporting

 


Additional Information

 

 

 

  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. .