Eli Lilly and Company

Clinical Data - Process/Technology Analyst

Location
Indianapolis, IN, United States
Posted
Oct 05, 2018
Ref
42790
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
The Associate Consultant - Process and Technology is responsible for providing technical leadership and process ownership for Global Statistical Sciences (GSS). There are three broad applications/focus areas for this role:
  • Apply specialized process/technology knowledge to ensure clinical trial deliverables are consistent, accurate and continuing to find efficiencies
  • Act as a primary contact within the GSS organization for development and support of process and technology
  • Communicate and adhere to the global data strategy across the organization as it relates to process and technology

Process/Technology Strategy Support (40%)
  • Define, deliver, and continuously improve global processes and/or technology to facilitate the reliable planning and execution of deliverables
  • Assist during the design and execution of clinical trials to ensure the development of the trial is consistent with the global data and analysis strategy, as applicable to focus area Identify, monitor and communicate global customer needs/requirements related to process and/or technology performance and enhancements
  • Ensure process and/or technology interfaces are optimized across Biometrics Provide business case analysis as needed for Biometrics initiatives, as applicable to focus area
  • Support the identification, communication, maturation and adoption of best practices and global standardized business processes, as applicable to focus area.
  • Marry deep phase/TA/geography expertise with deep process and/or technology expertise, as applicable to focus area.
  • Partner and/or strengthen relationships between key providers or customers, including influencing all roles across functions such as data scientists, statisticians, physicians, clinical pharmacology and clinical operations etc, as applicable to focus area.
  • Define, measure and achieve group proficiency with new tools/technology, processes, and the application of best practices as applicable to focus area.

Process Improvement (40%)
  • Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
  • Represent Biometric/GSS processes in cross-functional initiatives
  • Actively participate in shared learning across GSS
  • Work with partners to increase vendor/partner efficiencies

Business Office Support (15%)
  • Provide guidance and consulting into forecasting expenses
  • Build and maintain effective business partnership with teams, functions and affiliates understanding needs and ensuring timely response
  • Define and provide guidance related to vendor management
  • Provide business case analysis as needed for Biometric/GSS initiatives

Asset Protection (5%)
  • Understand the confidential nature of company information and takes necessary steps to ensure its protection.
  • This includes understanding various aspects of Privacy as it relates to the data managed within GSS.
  • Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
  • Accept obligation to Lilly for compliance to the integrity of the company
  • Complete readings of any policy/procedure updates including global medical, GSS and local policies and procedures
  • Specific focus area: GSS processes, technologies and standards.
  • Responsible for development of processes, documentation and training of GSS initiatives involving CDISC standards, clinical data flow processes and technology and submission deliverables.


42790BR

Basic Qualifications
  • Bachelor's degree
  • Minimum 3 years experience in clinical data management and/or 5 years experience in drug development within areas such as clinical operations, statistics, information technology, health outcomes, etc.
  • 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
  • Demonstrated knowledge of data and analysis processes and technology
  • Demonstrated ability to understand and apply data flow, data quality, data interchange, data mining, and data representation principles
  • Knowledge of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)
  • SCDM certification
  • Strong interpersonal and leadership skills
  • Excellent oral and written communication skills
  • Interpersonal/teamwork and communication skills for effective customer consultation
  • Strong business acumen
  • Demonstrated strength in logical thought, problem solving ability and strategic thinking
  • Ability to communicate and influence within Statistics.
  • Experience in training and rollout of project material
  • Demonstrated ability to navigate organizational change management when implementing new efficiencies


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.