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Clinical Outcomes Solutions logo
Clinical Outcomes Solutions

A global research consulting group providing 360° support & services across all facets of clinical outcomes research.

Principal Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteLeadTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

69 days ago

Salary

0

Seniority

Lead

Bachelor Degree8 yrs expEnglishJavaLinuxPythonUnix

Job Description

Principal Statistical Programmer

Clinical Outcomes Solutions

• Meetings and communications • Generate SDTM and ADaM specifications • Generate & QC assigned dataset domains • Support submission activities • Generate TLFs (patient profile, interim analysis, annual summary report, final CSR) • Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s) • Handling Data transfers to sponsor (or other designee) • Publication support • Ad hoc tasks/activities requested by sponsor • Writing SAS macros and other utilities and tools • Reviewing documents/specifications/output created by sponsor’s Partner CROs • Maintenance of associated tracking and validation documentation

Job Requirements

  • At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
  • 8+ years of experience as a Statistical Programmer in clinical Development environment
  • Excellent 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
  • Prior working experience with Oncology studies
  • 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.
  • Consistent training, development and support.

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