Clinical Data Scientist (Consultant)

The Clinical Data Scientist will serve as Aquestives in-house clinical data expert leading the execution of the clinical data analysis 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.

Responsibilities:

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.

Qualifications

• 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 manage multiple initiatives and shifting priorities within a small company environment.

Other Knowledge Skills and Abilities

• 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.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities duties and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestives employment process final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race color religion age sex national origin disability status genetics protected veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.