Analysis and Reporting Standards Consultant

Position: Analysis and Reporting Standards Consultant
Client: large biotech company
Location: 100% remote from anywhere in the US
Duration: through 2026 with possible extensions

What you will do
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 Client to promote the usage of standards. This role will have an opportunity to work across Client’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.

In this role you will:
• Build a comprehensive understanding of Client’s data standards structure across stages of development
• Build a comprehensive understanding of the Metadata Repository (MDR) product
• Develop mappings between Client’s ADaM and tables, figures, and listings standards within MDR
• Develop and maintain guidance documents supporting the analysis and reporting standards
• Ensure that Client 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

What we expect of you:
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