ClinChoice

1093#Senior Statistical Programmer, Early Stage Development and PK/PD Modeling and Simulation Consultant (Hybrid at PA/NJ)

ClinChoice

contract

Posted on:

Origin:  • 🇺🇸 United States • Pennsylvania, Washington

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Job Level

Senior

Tech Stack

SDLC

About the role

  • This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling and Simulation spanning all client therapeutic areas except oncology.
  • The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan.
  • The senior programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas.
  • Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
  • Ensure programmatic traceability from data source to analysis/modeling result
  • Support the development of programming standards to enable efficient and high-quality production of programming deliverables.

Requirements

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment
  • MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment
  • Excellent communication (oral, written) skills, interpersonal skills and ability to negotiate and collaborate effectively
  • Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings)
  • A project leader; completes tasks independently at project level
  • Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)
  • Experience in CDISC SDTM and ADaM standards
  • Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
  • Designs and develops complex programming algorithms
  • Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.