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Sr. Statistical Programmer in Rockvil...

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Sr. Statistical Programmer

Immunocore Rockville, MD (Onsite) Full-Time



Key Responsibilities

The role of the Sr. Statistical Programmer is to oversee and/or contribute to the delivery of the in-house deliverables including CDISC conversion; statistical programming contributions provided by Contract Research Organizations for clinical trials; to provide planned, ad hoc and exploratory statistical programming services including quality control; and to help create departmental systems, standards, and processes. This position is located onsite at our Rockville, MD office.

In close collaboration with Lead Study Biostatisticians, supporting statisticians, and clinicians; the Sr. Statistical Programmer will ensure that technical components that support the analysis, reporting, decision-making, publications, and regulatory submissions are delivered to a consistently high quality.

KEY RESPONSIBILITIES

  1. Create or perform a review and approval of technical specification documents
    o e.g. CDISC specifications, Tables, Figures and Listings (TFL) mock shells
  2. Create or perform a review and approval of externally delivered programming outputs, with a focus on quality
    o e.g. SDTM/ADaM datasets, TFL outputs
  3. Serve as a designated member of study team in the role of lead Statistical Programmer for clinical trial(s)
  4. Perform ad-hoc programming to support internal decision making
    o Delivery of SDTM, ADaM datsets, Tables, Figures and Listings
  5. Production and quality control of datasets and output to support:
    • Clinical study reports (CSRs)
    • Development Safety Update Reports (DSURs)
    • Periodic Benefit-Risk Evaluation Reports (PBRERs)
    • Investigator Brochures (IBs), etc.
  6. Production of datasets and output to support PK/PD analyses
  7. Undertake submission planning activities, for example:
    • Data pooling strategy
    • Programming input to High Level Documents
    • Response to regulatory questions
  8. Develop quality standards to drive efficiency and reuse of metadata
  9. Develop a comprehensive validation process for in house programming deliverables


Experience & knowledge

  • Mathematical, Statistical, Computer Science or Life Science degree with 5+ years of relevant experience.
  • Industry knowledge
    • Drug development lifecycle
    • CDISC standards
    • Extensive knowledge of Health Authority requirements
  • SAS programming skills
    • Base
    • Macro
    • SQL
    • SAS Graph
  • Experience a as lead programmer
  • Excellent written and verbal communication skills
  • A proven ability to solve problems, working independently of others
  • Experience of alternative programming languages, e.g. R, is desirable, but not essential


Education

A 4-year college degree from an accredited university. A degree or graduate in Statistics, Biostatistics, Computer Science, or related field is a plus.

Qualifications

Proficiency in SAS programming. SAS Certifications desirable
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Recommended Skills

  • Biology
  • Biostatistics
  • Clinical Study Reports
  • Clinical Trials
  • Decision Making
  • Drug Development

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