Clinical Data Scientist; Consultant

Aquestive Therapeutics | Corporate Office
30 Technology Dr
Warren, NJ 07059, USA

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. This role drives accountability at every possible level ensuring CROs are delivering quality data and documentation on time, on budget and to quality standards and SOPs.

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

Primary duties and responsibilities shall include, but are not limited to, the following:

• Clinical Data Management:
  • Monitor data management, programming, and/or bio‑statistical workflow of contracted CRO to maximize efficiency for all clinical trial data deliverables.
  • Collaborate with CRO and lead clinical teams in the generation/review SAPs and TLFs prepared by CRO to ensure quality and compliance with specifications.
  • Oversee data management‑related responsibilities, including trial start‑up, case report form (CRF) development, database build, edit checks, periodic reviews, etc.
  • Review external (third‑party) data transfer agreements; consult with CRO to integrate external data into 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 or final database lock.
  • Review of SDTM and ADaM dataset specifications/datasets prepared by CRO to ensure conformity to Clinical Data Interchange Standards Consortium (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, including but not limited to manuscripts, presentations, regulatory documents, corporate documents, etc.
  • 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 harboring clinical data for correctness in data presented, labeling of tables and figures, and discussion and overall messaging of data.

• B.S. degree in computer science, data science, and/or scientific or related scientific discipline.
• Proficient in Python.
• 3 years of experience in clinical data science and data management in a biotech or pharmaceutical company, or in a contract research organization servicing the pharmaceutical industry.
• Experience in development of clinical trial documents, including clinical data management plans, statistical analysis plans, statistical sections in protocol and study report, independent data monitoring committee charter and programming validation plans.
• Experience working in an outsourced data management model. 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 for clinical data management.
• Prior experience filing a BLA or NDA preferred.
• Demonstrated leadership in a cross‑functional team setting.
• Ability to…