Clinical Outcomes Solutions

Senior/Principal Statistical Programmer FSP

Clinical Outcomes Solutions

full-time

Posted on:

Location Type: Remote

Location: Poland

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Job Level

Senior

About the role

  • Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you.
  • The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members.
  • Responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
  • Participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.

Requirements

  • At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
  • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
  • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
  • Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
  • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
  • Must be able to work independently
  • Outstanding communication skills (written and verbal) and strong leadership skills.
Benefits
  • Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
  • We work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingstatistical programming proceduresCDISC standardsSDTMADaMDefine.xmlclinical trial methodologiesregulatory submissionsdata analysisbiostatistics
Soft Skills
communication skillsleadership skillsindependenceteam collaborationproblem-solvingattention to detailtime managementadaptabilitycritical thinkinginterpersonal skills