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Statistical Programmer (Senior)

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Statistical Programmer (Senior)

  • Location:

    Boston, United States

  • Sector:

    Life Sciences

  • Contact:

    Sam O'Donoghue

  • Job ref:

    512

  • Published:

    26 days ago

  • Expiry date:

    2020-12-31

Statistical Programmer (Senior)

Responsibilities:

Oversight and QC of CRO activities in

SDTM and ADAM Datasets development

Table / Listing / Figure (TLF) development and validation based on the Statistical Analysis Plan

TLF Mock shells development

Working with data management in providing programming support for DM activities including data review

Performing ad-hoc programming activities utilizing raw data based on internal and external requests

Contributing in process development, reviewing and development of SOPs related to statistical programming activities

Participate in Clinical Trial Teams, Data Review Teams, etc., and provide inputs from statistical programming perspective

Communicating with and/or responding to internal cross-functional teams and clients for project specifications, status, issues or inquiries

Collaboration with Statisticians and Data Management in planning study activities and ensuring study timelines are met

Performing lead duties when called upon

Requirements:

Ideally three or more years of experience in a Pharmaceutical company or a CRO as a SAS Programmer

Bachelor´s or Master´s degree in Informatics, Mathematics, Medical Documentation or other relevant qualification

Excellent ability in SAS data manipulation, analysis and reporting skills

Extensive experience in implementing CDISC SDTM, CDISC ADaM, and Define standards

Good knowledge of Table / Listing / Figure (TLF) programming, including SAS / STAT and SAS macro language and SAS graphic features

Good understanding of descriptive and inferential statistics

Proficient in industry standards, medical terminology and clinical trial methodologies

Submissions experience utilizing define.xml and other submission documents is a plus

Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Good communication skills and a good command of English language

Ability to work under pressure, flexibility and adaptability