Medical Statistician

Job Locations US-MA-Bedford
Posted Date 4 months ago(3/20/2020 5:56 PM)
Job ID
2020-1309
# of Openings
1
Category
Medical Affairs

Overview

The Medical Statistician is an integral part of the Medical Affairs team, driving data generation and dissemination strategies across products and assisting in overall strategic planning.  He/she will lead the development, coordination, performance, and validation of all statistical analyses in support of Medical Affairs, inclusive of overseeing the work of statistics and programming for external vendors as needed.  He/she will also be accountable for working collaboratively with internal and external partners to apply statistical methodology to clinical trials across various trial phases and types, and act as lead statistician for key projects.  Additionally, s/he will serve as the medical signatory on the internal promotional and medical review committees, ensuring all messages are medically accurate and appropriately cited.  As an excellent communicator and collaborator maintain effective communication with clients, study teams, and other internal partners.  Frequent cross-functional collaboration, both internal and external to the organization, is expected.

 

Responsibilities

Data and Evidence Generation Planning and Execution:

  • Collaborate with Medical Affairs Strategy and Operations Lead to support the development and execution of the Medical Affairs strategy and plan, specifically with the identification of data gaps and plans to fill these gaps
  • Assist the Manager of Late Phase Research and Grants in the development and execution of Phase 4 research trials and Investigator-Initiated Research program through collaboration with vendor(s) and clinical sites
  • Serve on the Investigator-Initiated Research Grants Review Committee
  • Identify educational gaps and data assessment needs to guide further research

Data and Evidence Dissemination Planning and Execution:

  • Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
  • Participate in publication planning and scientific communications platform planning and annual revision; contribute to plans including timelines, statistical and analytical requirements for publications, projects, and other key plans
  • Stay informed with data being generated in current clinical development programs
  • Assist medical writer(s) with the accurate interpretation of data sets

Project Management:

  • Track progress against strategic imperatives throughout the year
  • Develop reports tracking coverage and impact of programs to report to medical affairs and cross-functional teams
  • Provide administrative and operational support for executing Medical Affairs' overall goals and objectives as it related to grants and sponsorships and for assessing, summarizing, and distributing functional updates

Cross-Functional Collaboration:

  • Provide updates to internal stakeholders on medical affairs activities
  • Support annual budget and planning process
  • Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
  • Provide guidelines and standards to CROs to ensure quality of deliverables
  • Provide support for approval for commercial colleagues (e.g., payer requests)

Knowledge Management:

  • Serve as the medical signatory for promotional, and non-promotional materials on the Internal Review Committee ensuring accuracy, relevance and completeness, of scientific data and associated references
  • Review publications, marketing materials, and education and training materials that contain clinical data and product claims
  • Develop and maintain current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with products and relevant disease states
  • Create, review, and/or approve Data on File
  • Maintain reference library, bibliographies and eLibrary subscriptions (via RightFind management or other document management system)

Other:

  • Demonstrate the values of Ocular Therapeutix
  • Other duties as assigned

Supervisory Responsibilities:

May oversee the work of external consultants and manage multiple vendors

Qualifications

  • Advanced degree with health science background (PharmD, MD, PhD, or OD) preferred
  • 2+ years’ experience in Medical Affairs or related fields
  • Experience analyzing data using solid knowledge of statistical software (SAS, SPSS, etc.)
  • Experience in the ophthalmic pharmaceutical space preferred, but not required
  • Knowledge and understanding of the pharmaceutical commercialization process preferred
  • Ability to manage complex processes with multiple stakeholders
  • Management of consultants and vendors; proven planning and organizational skills with experience managing multiple priorities; attention to detail and the ability to prioritize in a changing environment
  • Ability to collaborate and communicate with cross-functional stakeholders
  • Excellent verbal & written communication skills
  • Ability to work with and collaborate will all levels and groups
  • Ability to travel 15%

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