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Senior Statistical Programmer

  • Permanent
  • Anywhere

Website Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Bingham Canyon, Utah

Post: Fri, 09 Sep 2022 03:29:25 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Responsibilities:

Input into and negotiate statistical programming timelines.

Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget

Monitor project resourcing, project budgets, and identify changes in scope

Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards

Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance

Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors

Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities

Requirements:

Proficiency in SAS

Knowledge of the programming and reporting process

Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-Google Cloud Platform and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application

Strong leadership skills

Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently

Excellent analytical skills

Effective time management in order to meet daily metrics or team objectives

5+ years proficiency in SAS programming

2+ years of ADaM, CDISC or SDTM

Lead experience in a Pharma setting

Attention to detail, ability to be self-driven and solid organization skills

Excellent communication skills (verbal and written)

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