Clinical Data Scientist (Consultant)

Aquestive Therapeutics•Warren, NJ

About The Position

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.

Requirements

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.
Demonstrated leadership in a cross-functional team setting.
Ability to manage multiple initiatives and shifting priorities within a small company environment.

Nice To Haves

Prior experience filing a BLA or NDA preferred.
Proven ability to be innovative.
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.
Must maintain a professional demeanor, as well as a pleasant manner and positive “can-do” attitude while developing and maintaining communications in a cooperative and collaborative manner with all levels across functional teams both internally and externally.
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
Flexibility to change priorities and be comfortable with the changing deadlines to meet organization needs when required.
Must be detail-orientated, with the ability to work on multiple projects with overlapping schedules and priorities.
Highly motivated and a self-starter; demonstrated ability to work independently, as well as in a team while exercising discretion; takes initiative to resolve problems.
Possess a blend of business and scientific knowledge, and interpersonal skills; effective communication (both orally and in writing) and excellent listening skills; strong customer service orientation.

Responsibilities

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.
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.
Review documents harboring clinical data for correctness in data presented, labeling of tables and figures, and discussion and overall messaging of data.