Senior Statistician

Baltimore, Maryland

This job has expired.

Come Join Our Growing Team!

We are looking for a Senior Statistician to join our team. The Senior Statistician will be accountable for the leadership of the statistics activities of a collection of studies that are of high value to the organization. Also responsible for the activities of junior statisticians and programmers working on the assigned program of studies to ensure studies are delivered on time, on budget, and to the required quality.

What The Job Entails:

  • Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for
    assigned studies.
  • Provided statistical oversight to studies and assure adequate quality and consistency with project requirements.
  • Attend (as appropriate) client meetings including, but not limited to, project kick-off meetings, resource/timelines discussions, bid
    defenses, blind data review meetings, etc.
  • Manage activities of statisticians by appropriately coordinating assignments and reviewing work so that projects are delivered on time
    with high quality.
  • Review case report form and other data management documents including, but not limited to edit check specifications, data review
    plan, data transfer specification etc.
  • Review/validate programming deliverables including, but not limited to programming specifications, analysis datasets and tables, figures,
    and listings to ensure to meet the analysis requirements. Ensure the interpretation of the results are accurate.
  • Mentor statistical programmers on understanding of statistical design, and the implementation of statistical models.
  • Ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards.
  • MS or PhD in Statistics, Biostatistics or related field. PhD with 2-3 years of experience or MS with 4-6 years of experience in
    pharmaceutical or related industry experience with clinical trials.
  • Solid knowledge of statistics.
  • Compliance in SOPs/WIs, ICH-GCP and any other applicable local and international regulations, guidelines and industry standards.
  • Show commitment to and perform consistently high-quality work.
  • Excellent communication skills in both verbal and written English.
  • Timeline adherence, reliability, good efficiency, attention to details.
  • Initiative, problem solving and take extra responsibility.
  • Familiar with SAS Base, SAS/Macros, SAS/Graph, SAS/Stat, and reporting process.
  • Familiar with CDISC CDASH/SDTM/ADaM standards.

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