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To perform tasks under the guidance of project lead or CMC departmental principals on analytic design and statistical analytic planning, coordinate real world database management, and data warehouse construction or maintenance; to develop documentations of analytic plans, prepare for statistical ...

Job Description

To perform tasks under the guidance of project lead or CMC departmental principals on analytic design and statistical analytic planning, coordinate real world database management, and data warehouse construction or maintenance; to develop documentations of analytic plans, prepare for statistical concept communications and be able to advise on analytic strategies and recommend methodological solutions on complex analytic topics; to lead and perform statistical analysis, modeling, reporting, analytic interpretations, and slide development; to develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures to standard metrics for product value propositions; to construct drug coding systems to support database activities for key therapeutic R;D and brand LCM activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems ; to establish and main variety of disease identification and composite comorbidity assessment tools and algorithms; to conduct analytic quality assurance procedures; to provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications; to provide analytic support for internal and external communications and statistical interpretations of data under the guidance of departmental methodological principals. Roles ;

Responsibilities:

  • Analytic process formulation and standardization
  • Vendor Management
  • Plan and initiate analytic projects using the real world databases or clinical trial data warehouse in support of the CMS initiatives
  • Prepare communication materials on analytic projects including processes, data, analytic findings for internal and external functional groups within or outside of CMS
  • Assist project lead or departmental principals in study design, power calculation, CRF construction, analytic operations and reporting for retrospective and prospective studies
  • Develop statistical analytic plans, statistical expertise and data management techniques and skills
  • Manage real world database operations, analytic programming and statistical modeling activities
  • Assist project lead or departmental principals in analytic/computing resource planning,, work flow management and prioritization, and related logistic coordination
  • Prepare slide decks for congress or manuscript submissions or internal or external communications
  • Provides consultation for all CMS groups on research methodology and statistical or analytic issues
  • Database licensing and maintenance
  • Potentially supervising team of analytic and programming support


Under the guidance of supervisor

  • Bring statistical support around computational approaches toward discovering and developing Biotherapeutics (use of in silico methods - modelling, simulation, machine learning, computational biophysics - for improving bioprocess yields, biophysical stability, and safety profiles of biopharmaceuticals)
  • Bring statistical support in the design of experimental protocols, in the realization and interpretation of the results of statistical analyses and their presentation, - to take in charge the statistical analysis of complex or critical studies, generally intended to Health Authorities with writing of statistical study rapports according to the practices/standards of the Department and to participate to the answer to the questions from the Agencies on the registration dossiers and on various regulatory variations/commitments
  • Familiar with JMP, SAS and R.