Principal Statistical Programmer

PUB353844

About this job

  • Branche: Biotechnology
  • Area of expertise: Study & Science
  • Location: United States

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor

About this role: Principal Statistical Programmer

We’re hiring a Principal Statistical Programmer for an oncology biotech client. This candidate will provide expert-level hand-on principal programming support and technical leadership to develop, maintain, validate, and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. They will perform the statistical programming required for analysis of clinical trial data on projects of moderate to high complexity for in-house and out-sourced clinical trials, commercial requests, Health Economics Outcome Research (HEOR) analyses, integrated analysis such as integrated summary of efficacy (ISE) and integrated summary of safety (ISS) and any other ad-hoc analysis required.

  • Acts as lead and takes ownership of multiple studies within a drug program whilst providing support across various drug platforms.
  • Acts as an integral member of project team. Attends project team meetings, works with vendors, biostatisticians, data managers, and clinical trial managers, as appropriate
  • Leads Submission Working Group programming activities related to ISS and ISE deliverables
  • Serve as a lead programmer in the production of all tables, listings, and figures, and Case Report Form (CRF) tabulations for clinical trial programs including ISS/ISE
  • Serve as a lead programmer to support regulatory requests, commercial requests, ad hoc analyses, biomarker analyses, HEOR analyses etc.
  • Evaluates and/or identify opportunities for standardization across projects.
  • Reviews critical Standards Artifacts and Processes (such as Statistical Analysis Plans, Data Validation Plans, eCRFs, etc.) and provides constructive comments
  • Helps solve critical issues requiring SAS expertise
  • Troubleshoots and provides quality review of complex SAS programs
  • Communicates strategically with CROs regarding SAS technical expertise and project requirements.
  • Codes SAS utility macros; writes and implements test plans to support SAS macro development
  • Programs statistical analyses (i.e., tables, listings, figures, and inferential statistical output) using SAS supporting commercial requests, regulatory requests, ad-hoc analysis, integrated analysis such as ISS and ISE
  • Follows good programming practices and adequately documents programs
  • Understands and follows FDA regulations which affect the reporting of clinical trial data
  • Participates in cross functional task forces and initiatives representing Statistical Programming

Requirements

  • B.A. / B.S. with at least five years of relevant experience or an M.S. with three years of experience
  • Good analytical skills
  • Ability to communicate technical concepts clearly and concisely to non-technical colleagues
  • Strong organizational skills, attention to detail, and the ability to learn technical and clinical aspects of a clinical trial
  • Successfully completed several large or complex projects
  • Detail oriented
  • Ability to handle multiple projects with aggressive timelines
  • Leader and team player
  • Ability to multitask and prioritize work
  • Excellent knowledge of SAS
  • Familiarity with coding dictionaries (WHO, MedDRA)
  • Knowledge of pharmaceutical standard initiatives such as CDISC
  • Knowledge of medical and statistical terminology
  • Capable of using Windows, Word, Excel
  • The ability to work independently and expert SAS programming experience is required

Benefits

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Any questions remaining?

Your consultant, Max Schumacher is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB353844

Account manager

Max Schumacher
Brunel USA - Minneapolis
m.schumacher@brunel.net

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