Clinical Data Scientist; Consultant

Job Summary

The Clinical Data Scientist will serve as Aquestive’s in‑house clinical data expert leading the execution of the clinical data analysis pipeline. The ideal candidate will have diverse and hands‑on experience in both clinical data management and data analysis.

This individual will be responsible for oversight of programming and data management activities with contract research organization (CRO) vendors in support of Phase I–Phase IV clinical trials. The role drives accountability at every level, ensuring CROs deliver quality data and documentation on time, on budget, and in compliance with quality standards and SOPs.

Under minimal supervision, the Clinical Data Scientist will also conduct in‑house statistical and data analyses at the subject, study, and program levels, review clinical data outputs according to internal and regulatory standards, and work with team members (internal and external) to resolve clinical data issues proactively.

• Clinical Data Management
  • Monitor data management, programming, and/or biostatistical workflow of contracted CROs to maximize efficiency for all clinical trial data deliverables.
  • Collaborate with CROs and lead clinical teams in the generation/review of SAPs and TLFs prepared by CRO to ensure quality and compliance with specifications.
  • Oversee data management responsibilities, including trial start‑up, CRF development, database build, edit checks, periodic reviews, etc.
  • Review external data transfer agreements and consult with CRO to integrate external data into the study programming process flow.
  • Ensure clinical data within EDC is of high quality to support lock/unlock as appropriate for statistical review, interim review, and final database lock.
  • Review SDTM and ADaM dataset specifications and datasets prepared by CRO to ensure conformity to CDISC implementation guidelines and standards.
  • Provide/facilitate support as needed, both technical and clinical, to ensure efficient action, collaboration, and resolution of issues.
• Clinical Data Analysis, Visualization and Interpretation
  • Program ad‑hoc statistical and data analyses and generate presentations for data review meetings or in response to requests by clinical, medical and regulatory teams.
  • Maintain all relevant programming documentation for designs, scripts, and other processes.
  • Read, validate and execute previously generated programs to update clinical data outputs.
  • Participate in validation and quality checks of statistical programming and output produced both internally and externally.
• Clinical Data Quality Control and Assessment
  • Review documents containing clinical data for correctness in data presented, labeling of tables and figures, and overall messaging.

• B.S. degree in computer science, data science, and/or a related scientific discipline.
• Proficiency in Python.
• At least 3 years of experience in clinical data science and data management in a biotech or pharmaceutical company, or in a CRO servicing the pharmaceutical industry.
• Experience in developing clinical trial documents, including data management plans, statistical analysis plans, statistical sections in protocol and study report, independent data monitoring committee charters, and programming validation plans.
• Experience working in an outsourced data management model, including vendor oversight of Data Management, SAS Programming, and/or statistical deliverables.
• Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
• Familiarity with GCP, ICH, and FDA requirements as applicable to clinical data management.
• Prior experience filing a BLA or NDA preferred.
• Demonstrated leadership in a cross‑functional team setting.
• Ability to manage multiple initiatives and shifting priorities within a small company environment.

• Proven ability to innovate.
• Proven ability to implement GCP guidelines.
• Ability to function as a lead team member on clinical trial project teams.
• Familiarity with WHODrug and MedDRA coding dictionaries.
• Strong knowledge of MS Word, Excel, PowerPoint, Access, and Outlook.
• Maintain a professional…