Biomedical Analysis Consultant

Payrate: $60.00 - $65.00/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 at Company to promote the usage of standards.

This role will have an opportunity to work across Company’s 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.

• Build a comprehensive understanding of Company’s data standards structure across stages of development
• Build a comprehensive understanding of the Metadata Repository (MDR) product
• Develop mappings between Company’s 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

• 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

• 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

• Extensive clinical trial support with emphasis on the creation of specifications for ADaM data and tables, figures and listings including the usage of standards
• Proficient in CDISC ADaM modeling and CDISC IGs and TAUGs
• Strong understanding of end-to-end standards and data flow

Pay Transparency: The typical base pay for this role across the U.S. is:$60.00 - $65.00/hr
.Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages.

Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus.

Sick leave and mobile phone reimbursement provided based on state or local law.

#Aditi Consulting

# 26-04058