Director, Clinical Data Science

  • Location:Cambridge,MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

RESPONSIBILITIES:

  • Responsible for developing and/or leveraging tools for long term, scalable, practical solutions for medical, clinical and translational data integration, review and visualization supporting the Surface clinical portfolio
  • Delivery of program level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Surface portfolio
  • Key technical clinical data integration expert; may define and drive the data integration strategy and standards for Surface
  • Ensure oversight of work carried out by or on behalf of Clinical Data Science in accordance with applicable SOPs, regulations and working practices
  •  Working with internal colleagues to design and execute data analysis plans, and to summarize the actionable findings to support both exploratory research and Biologics License Applications
  • Develop and validate the analysis workflow, software applications, and data warehouse to improve visualization, integration, and accessibility of complex clinical data
  • Designs, develops, and implements methods, processes and systems to consolidate and analyze diverse data sets including structured and unstructured.
  • Develops or oversees software programs, algorithms, dashboards, information tools, and queries to clean, model, integrate and evaluate datasets
  • Keeps abreast of new analytic methodologies and technologies. Collaborates with functional business units to drive business solutions and direction.
  • Contribute to review and development of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems
  • Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals, and clinical research collaborations as required
  • Collaborate with VP, Clinical Development Operations to plan, build and lead Clinical Data Science organization

 

EDUCATION AND EXPERIENCE: 

  • 10-15 years relevant experience with at least 2-3 years in biotech environment
  • Degree in computer science or related technical discipline
  • Experience in oncology therapeutic areas
  • Be able to demonstrate understanding of clinical research, the drug development process, GCP, CDISC (SDTM, CDASH, ADaM, & SEND) requirements and related regulatory guidelines
  • Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment
  • Prior experience in successful implementation utilizing and leveraging outsourcing strategies
  • Experience using EDC products (Medidata RAVE preferred) and data visualization tools (e.g. Spotfire, jReview)
  • Experience with evaluating, implementing and managing infrastructure (storage/compute/networking), enterprise systems, and core services
  • Flexibility/adaptability to work in a fast-paced and dynamic environment
  • Very strong organizational, verbal, written, and presentation skills
  • Ability to adapt to increasing scope and complexity of work brought on by growth/change and helps others manage through change