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MMS logo
MMS

The difference is in the data.

Principal Biostatistician

Clinical ResearchClinical ResearchFull TimeRemoteLeadTeam 501-1,000H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

97 days ago

Salary

0

Seniority

Lead

Postgraduate Degree7 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

Principal Biostatistician

MMS

• Lead complex projects, programs and submissions • Manage client meetings and collaborate with regulatory, PMs and sponsors • Develop SAPs and iSAPs text and shells with no supervision • Produce and present external company presentations • Review or develop ADAM specifications and collaborate with programmers and junior statisticians • Provide statistical consulting support to sponsors regarding study design and sample size calculations • Demonstrate an understanding of project management-related tasks • Perform sample size calculations • Create randomization and kit schedules independently • Provide support to Data Safety Monitoring Boards (DSMB) • Write blogs and/or white papers for posting on the company website

Job Requirements

  • Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred
  • Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required
  • Submission experience (ISS/ISE)
  • High-level knowledge of drug development as it pertains to biostatistics
  • Expert knowledge of scientific principles and concepts
  • Good communication skills and willingness to work with others
  • Good organizational skills
  • High proficiency with MS Office applications
  • Hands-on experience with clinical trial and pharmaceutical development preferred
  • Excellent problem-solving skills
  • Familiarity with current ISO 9001 and ISO 27001 standards preferred
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements
  • Good understanding of CROs and scientific & clinical data/terminology, & the drug development process

Benefits

  • Supportive, innovative team environment
  • Great Place to Work certified

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