Summary

Responsibilities

• Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
• Adopts strategic approach to producing and prioritizing analytical deliverables which includes study level or integrated analysis for safety signal detection or other business needs.
• Work with data management to review case report forms, database specifications, and data transfer specifications
• Manage on-time and quality delivery of CRO-generated analyses results.
• Solid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements.
• In-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data types.
• Responsible for creating/reviewing SDTM/ADaM mapping specifications.
• Generates or validates SDTM domains, ADaM datasets, reviewer's guide, and define.xml files.
• Generates or validates TFLs to support the statistical analysis of data for clinical studies, regulatory submissions, and publications such as CSR, DSUR, IB, publications, etc.

Qualifications

• Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
• 8+ years programming experience with growing responsibility in biotechnology or pharmaceutical clinical trial environment.
• Experience in software development and testing (e.g., SAS Macros tools, R functions/packages, Unix scripts etc).
• Experts in developing applications using various technical stacks not limited to SAS, R and/or Python.
• Solid understanding of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM.
• Proven ability to translate sophisticated problems into clear and concise programming code/tools.
• Basic Project management skills and experience.
• Solid understanding of programming practices (including tools and processes), relevant health authority guidelines, such as (e.g., ICH‐GCP, 21 CFR Part 11), and relevant clinical R&D concepts.
• Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities and to negotiate successfully.

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