Data Scientist II

1 day ago

San Francisco, United States Tellus Solutions Full time

Tellus Solutions is in partnership with a committed biopharmaceutical company focused on providing innovative therapies. Your technical expertise as a Data Scientist II in the area of HEOR will contribute to our client's innovative therapies which will impact the quality and duration of life

Job Description:
Purpose:

  • The Manager, Patient Experience Data & Strategy role within the Patient-Centered Outcomes Research (PCOR) team works independently while under the supervision of a Director to design and execute patient experience data (PED) evidence research to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial).
  • He/She develops research plans outlining the strategic approach for generating required evidence and research outputs, which may span multiple products / indications. This research includes literature and landscape reviews, the development and validation of Clinical Outcome Assessments (COAs), and analyses of COA endpoints. In addition, he/she supports integration of COA measurement strategies into clinical development programs and develops high-quality documentation to summarize PED for communication in regulatory submissions.
  • He/She presents research findings internally to stakeholders within Client and externally. In addition, the Manager builds research relationships with key external thought leaders, fostering industry research collaboration.
  • The employee must conduct their work activities in compliance with all Client internal requirements and with all applicable regulatory requirements.
Responsibilities:
  • Conducts literature & landscape reviews to identify concepts of importance to patients to develop disease conceptual models
  • Identifies & evaluates existing COA tools to determine the extent to which the assessments are fit-for-purpose
  • Leads development & integration of COA measurement strategy into clinical development programs through clinical trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensures appropriate implementation of COAs on eCOA platforms in global programs
  • Leads design and execution of qualitative research, psychometric analyses, and development of new COA tools
  • Contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints
  • Develops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
  • Contributes to development of PED standards/best practices and educational resources for functions across Client to drive the integration of patient voice in development programs
  • Develops and manages publication creation, review / approval, submission and presentation of research in peer-reviewed journals and at medical / methodological congresses
Qualifications:
  • dvanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
  • Professional experience and training preferred (minimum 2 years of research experience required. Work experience can include fellowship experience)
  • Firm understanding of the scientific fundamentals of COA research & measurement science
  • bility to work collaboratively
  • Strong interpersonal skills with an ability to leverage expertise to understand, respond effectively across stakeholders
  • Demonstrated ability to manage multiple projects involving complex processes, significant budget, competing deadlines and rapidly shifting priorities
  • Strong written and verbal communication skills
  • Experience in handling delivery of services across complex environments
  • Experience in managing projects from design through execution
  • Some experience / knowledge of the pharmaceutical industry (knowledge of regulatory/compliance frameworks) and clinical trial design
  • Demonstrated initiative and strong work ethic
  • Willingness to travel as required

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