Consultant Data Standards Fixed Duration Employment
Company Name:
Eli Lilly
Company Overview
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
This position will focus on SDTM portfolio delivery.
The Clinical Data Flow and Technology (CDFT) department within Biometrics and Advanced Analytics is responsible for:
Standards Influence, define, and instantiate core and therapeutic area standards for broader reusability and drive toward consistency; understand, influence, and incorporate industry standards (CDASH, SDTM, ADaM, ODM).
CDF Technologies and Process Define, Implement and Manage the processes and technologies, (i.e., InForm, CIS, ClinTrial, Integrations, SDD, CDI, and niche statistical software) to support the Clinical Data Flow from data collection through analysis/integrated databases/submission deliverables.
Portfolio Support the portfolio by enabling delivery of observed and analysis data at the study along with delivery of PK data sets, Integrated Data Bases and submission deliverables.
People - Providing solution consultation to support CDF processes utilizing process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, CFR 21 Part 11, guidance documents.
Maintaining libraries of clinical trial data standards accessible to all Lilly personnel
Ensuring facility of data transfer between Lilly and external partners by defining relationships between internal and external standards
Developing metadata used to control and automate the clinical trial dataflow process
Data Standards Development and Maintenance (30%)
Develop standards for transformations of source data into Analysis Data Sets and Submission Data Sets, including derived variable standards
Develop metadata used to automate and control the clinical trial dataflow process
Maintain standards compliant library components (i.e. forms, panels, rules, derivations).
Influence the organization to adopt standards and ensuring that standards are created in a timely way when not available
Deliverable Ownership (45%)
Define data deliverables and ensure their successful delivery
External Influence (10%)
Engagement with external data standards organizations (i.e. CDISC)
Participation on external committees to develop and influence industry standards
Understand data standards external to Lilly (e.g. CDISC) and facilitate mapping between internal and external data standards for both submission and when dealing with vendors and other third parties
Process Improvement (10%)
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Represent Data Sciences processes in cross-functional initiatives
Actively participate in shared learning across Data Sciences and Solutions.
Work with partners to increase vendor/partner efficiencies
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 Data Sciences and Solutions.
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, Data Sciences and Solutions, and local policies and procedures
Basic Qualifications
Bachelors degree preferably in Medical Informatics, Information Technology or Statistics
Minimum of 5 years experience in clinical data management, data standards, IT or Statistics or 6 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, health outcomes, etc.)
3 years of experience with implementing CDISC SDTM
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 these positions.
Additional Skills/Preferences
Strong interpersonal and leadership skills
Excellent oral and written communication skills
Project management skills
Familiarity with SQL, ORACLE, XML
Knowledge of medical terminology
Vendor management/oversight skills
Technical aptitude in the area of CDISC standards
Strong clinical knowledge and ability to liaise effectively with Data Sciences Consultant and Project Statistician
Ability to articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data standard development
Familiarity with clinical data standards tools and technologies
Demonstrated programming knowledge and ability to apply knowledge to the development of standards and/or project deliverables
Familiarity with CDISC xstandards used external to Lilly (e.g. SDTM, ODM, ADaM, HL-7)
Additional Information
This position is not permanent. It is for a fixed duration for up to 4 years.
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status
Apply online at:
https://xjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=10740BR&Codes=IMBEstimated Salary: $20 to $28 per hour based on qualifications.
Eli Lilly
Company Overview
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees in competitive salaries, training and development, and health.
The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.
Responsibilities:
This position will focus on SDTM portfolio delivery.
The Clinical Data Flow and Technology (CDFT) department within Biometrics and Advanced Analytics is responsible for:
Standards Influence, define, and instantiate core and therapeutic area standards for broader reusability and drive toward consistency; understand, influence, and incorporate industry standards (CDASH, SDTM, ADaM, ODM).
CDF Technologies and Process Define, Implement and Manage the processes and technologies, (i.e., InForm, CIS, ClinTrial, Integrations, SDD, CDI, and niche statistical software) to support the Clinical Data Flow from data collection through analysis/integrated databases/submission deliverables.
Portfolio Support the portfolio by enabling delivery of observed and analysis data at the study along with delivery of PK data sets, Integrated Data Bases and submission deliverables.
People - Providing solution consultation to support CDF processes utilizing process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, CFR 21 Part 11, guidance documents.
Maintaining libraries of clinical trial data standards accessible to all Lilly personnel
Ensuring facility of data transfer between Lilly and external partners by defining relationships between internal and external standards
Developing metadata used to control and automate the clinical trial dataflow process
Data Standards Development and Maintenance (30%)
Develop standards for transformations of source data into Analysis Data Sets and Submission Data Sets, including derived variable standards
Develop metadata used to automate and control the clinical trial dataflow process
Maintain standards compliant library components (i.e. forms, panels, rules, derivations).
Influence the organization to adopt standards and ensuring that standards are created in a timely way when not available
Deliverable Ownership (45%)
Define data deliverables and ensure their successful delivery
External Influence (10%)
Engagement with external data standards organizations (i.e. CDISC)
Participation on external committees to develop and influence industry standards
Understand data standards external to Lilly (e.g. CDISC) and facilitate mapping between internal and external data standards for both submission and when dealing with vendors and other third parties
Process Improvement (10%)
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Represent Data Sciences processes in cross-functional initiatives
Actively participate in shared learning across Data Sciences and Solutions.
Work with partners to increase vendor/partner efficiencies
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 Data Sciences and Solutions.
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, Data Sciences and Solutions, and local policies and procedures
Basic Qualifications
Bachelors degree preferably in Medical Informatics, Information Technology or Statistics
Minimum of 5 years experience in clinical data management, data standards, IT or Statistics or 6 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, health outcomes, etc.)
3 years of experience with implementing CDISC SDTM
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 these positions.
Additional Skills/Preferences
Strong interpersonal and leadership skills
Excellent oral and written communication skills
Project management skills
Familiarity with SQL, ORACLE, XML
Knowledge of medical terminology
Vendor management/oversight skills
Technical aptitude in the area of CDISC standards
Strong clinical knowledge and ability to liaise effectively with Data Sciences Consultant and Project Statistician
Ability to articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data standard development
Familiarity with clinical data standards tools and technologies
Demonstrated programming knowledge and ability to apply knowledge to the development of standards and/or project deliverables
Familiarity with CDISC xstandards used external to Lilly (e.g. SDTM, ODM, ADaM, HL-7)
Additional Information
This position is not permanent. It is for a fixed duration for up to 4 years.
Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status
Apply online at:
https://xjobs.brassring.com/tgwebhost/jobdetails.aspx?PartnerId=25428&SiteId=5645&Areq=10740BR&Codes=IMBEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
