Overview
Remote
On Site
Hybrid
$62 - $64 hr
Contract - W2
Contract - Independent
Contract - 12+ mo(s)
Skills
ADAM
SPECIFICATIONS
SPECS
METADATA REPOSITORY
MDR
META DATA REPOSITORY
DATA
CLINICAL DATA
SDTM
STANDARDS
GOVERNANCE
Job Details
Payrate: $62.00 - $64.00/hr.
Summary:
In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the end-in-mind as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS but may also collaborate with statisticians and statistical programmers to promote the usage of standards. This role will have an opportunity to work across therapeutic areas to create and maintain clinical trial data standards. This role will also have the opportunity for the development of a standards data repository connecting the ADaM standards with the table, figure, and listings standard specifications.
Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Pay Transparency: The typical base pay for this role across the U.S. is: $62.00 - $64.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22362
Summary:
In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the end-in-mind as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS but may also collaborate with statisticians and statistical programmers to promote the usage of standards. This role will have an opportunity to work across therapeutic areas to create and maintain clinical trial data standards. This role will also have the opportunity for the development of a standards data repository connecting the ADaM standards with the table, figure, and listings standard specifications.
Responsibilities:
- Build a comprehensive understanding of data standards across stages of development
- Build a comprehensive understanding of the Metadata Repository (MDR) product
- Develop mappings between ADaM and tables, figures, and listings standards within MDR
- Develop and maintain guidance documents supporting the analysis and reporting standards
- Ensure that decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry and regulatory guidance
- Provide input to continuously improve the management of analysis and reporting standards and metadata
Basic Qualifications:
- Doctoral degree and 4 years clinical trials experience OR
- Master s degree and 6 years clinical trials experience OR
- Bachelor s degree and 8 years clinical trials experience
- Proficient in CDISC ADaM modeling and CDISC IGs and TAUGs
- Effective communication and collaboration skills
Preferred Qualifications:
- 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming
- Proven standards development experience
- Experience in designing, analyzing, and reporting clinical trials
- Experience working with multiple relevant programming languages (for example, SAS, R, JavaScript, CSS, Python, VBA, etc.)
- Independent and self-motivated
Pay Transparency: The typical base pay for this role across the U.S. is: $62.00 - $64.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22362
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.