Digital Health Biostatistician

Company: Cytel Software Corporation
Location: Rockville
Posted on: June 18, 2022

Job Description:

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of drug development. In this role you will join our FSP department and will for our client, one of the top pharmaceutical companies.We are seeking digital health biostatistician to fill a post-submission and RWE role with a major client. This individual should early to midway in his/her career as a statistician in the healthcare industry and looking to take on a technical leadership role in such an environment. The expectation is this person will be able to bring computational, operational and production experience to drive efficiency in evidence generation using CDISC, Claims, and raw biological data.You will contribute by:

• Understand, interpret and integrate data from various sources to ensure clinical/biological/regulatory questions can be answered appropriately with the available data.
• Creation of SAP. Participate in creation of CRF, and protocol development.
• Creation and statistical programming of high quality and well documented data manipulation, analysis, outputs and reports.
• Identify, communicate and be strongly vocal about potential issues and limitations in statistical analysis and result interpretation to stake holders.
• Provide statistical consultation to clinician scientist to frame biological questions into statistical hypothesis and explore raw biological data.
• Plan, understand, manage expectations of stake holders in terms of project resourcing, feasibility, deliverables, and timeline.What were looking for:
  • Master degree or higher in a statistical subject
  • 1-3 years of experience in a regulated environment (e.g. CRO, Pharmaceutical Company, Governmental regulatory body, health services provider.)
  • You have a good understanding of statistical issues in both clinical trials (and other randomized experiments) and observational studies (e.g. comparative cohort studies, case-control, retrospective/prospective cohort and registry).
  • You will have experience in statistical analysis in a clinically related subject, either within clinical trials or in Epidemiology, either academically or professionally and/or Outcomes research.
  • You are able to work independently and in a team.
  • You are confident, self-reliant, and a quick learner.
  • You have strong knowledge of either R or SAS.
  • Good oral and written English communication skills are mandatory.Recommended:
    • Strong computational and software development experience in R, SAS or Python (e.g. degree in computer science/data science/software engineering, previous experience as software developer, publication in computational statistics, R/SAS package/repository)
    • Extensive experience leading post-submission evidence generation using CDISC data and Claims data (e.g. for NICE, Market Access of various country, Reimbursement)
    • Extensive work experiences with neurological diseases (e.g. author/co-author of papers in peer reviewed journals in Neurological diseases, conference presentations in ACTRIMS, AAN)Whats in it for you:
      • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
      • You will be part of an exciting new chapter in Cytels history with high growth and opportunities to progress in Senior and Leadership positions within the company
      • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
      • Work with and leverage the best and brightest minds in the industry#LI-KO1#CYTELINTRequired
        Preferred

        Job Industries

        • Customer Service

Keywords: Cytel Software Corporation, Rockville , Digital Health Biostatistician, Other , Rockville, Maryland