• Contract
  • Remote

SimulStat

Remote, 6-month contract, likely to extend

Senior Statistical Analyst

General Summary:

The Senior Statistical Analyst is responsible for supporting comprehensive programming activities including the production and quality control of CDISC datasets and tables, listings, and figures. 

Principal Duties and Responsibilities:

  • Work independently and effectively to complete assignments across multiple projects with minimal supervision
  • Provide functional expertise to the conduct of programming activities in accordance with current standards, regulatory requirements, SOPs and work practices
  • Review statistical analysis plan and other study documents, provide input, assess impact on programming activities, and ensure programming assumptions and requirements meet study objectives
  • Conduct data analyses in accordance with protocol requirements (e.g. interim, final and data monitoring committee meetings), for publication, board meetings (e.g. safety, scientific, corporate), and clinicaltrials.gov postings
  • Create, or review and approve CDISC compliant datasets and corresponding documentation for electronic submission to regulatory agencies
  • Proactively plan, implement, and identify issues/risks associated with the programming activities and provide remediation strategies
  • Set, manage, and meet realistic timelines for projects
  • Participate in the development of Clinical Study Reports, Investigator Brochures, NDAs/BLAs, Annual Reports/DSURs, INDs as appropriate

Qualifications:

Education

  • Bachelor’s degree or higher in statistics, biostatistics, computer sciences, or related field

Experience/Skills

  • Minimum 5 years of experience in the biotechnology or pharmaceutical industry with at least one year of experience in oncology studies
  • Excellent SAS skills for data analysis, visualization, and reporting
  • Experience working with all types of safety data and coding dictionaries (MedDRA and WHODDE)
  • In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases
  • Knowledge of Good Clinical Practices, ICH guidelines, FDA guidance, trial initiation and management practices and procedures
  • Solid interpersonal and communication skills
  • Works efficiently with others to accomplish goals and resolve problems; encourages cooperation, collaboration, and co-ownership of processes

Position Requirements:

  • Ability to work on complex problems where analysis of situations or data visualization requires an in-depth evaluation of various factors
  • Willing to travel for training, audits, conferences, or other events or meetings in support of biometrics or corporate goals

 

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