Principal Statistical Programmer, North America

Software EngineerSoftware EngineerFull TimeRemoteTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Arizona + 4 moreAll locations: Arizona, California, Maine, Ohio, Rhode Island

Posted

25 days ago

Salary

Not specified

Bachelor DegreeExperience acceptedEnglish

Job Description

• Uses R, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications • Works to ensure that outputs meet quality standards and project requirements • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings • Keeps project team members informed of programming progress and issues requiring their attention • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements • Anticipates and addresses potential programming issues • Conducts effective internal meetings (appropriate in format, frequency and attendance) • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business • Accountable for on-time delivery across concurrent programming deliverables • Acts as the lead statistical programmer • Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements

Job Requirements

  • Previous Industry Experience within R is required
  • Must be eligible to work within North America without Sponsorship
  • Undergraduate degree, preferably in a scientific or statistical discipline
  • Extensive programming experience in SAS and R or other required software, preferably in a clinical trial environment
  • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
  • Experience in submissions to a regulatory agency preferred
  • Experience in mentoring others in clinical trial process and CDISC Standards
  • Excellent written and verbal communication skills
  • Ability to read, write, speak and understand English.

Benefits

  • Health benefits to include Medical, Dental and Vision
  • Company match 401k
  • Eligibility to participate in Employee Stock Purchase Plan
  • Eligibility to earn commissions/bonus based on company and individual performance
  • Flexible paid time off (PTO) and sick time

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