Astellas Pharma Statistical Programming Manager in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Statistical Programming Manager opportunity in Northbrook, IL.

Purpose & Scope

This position is accountable for the statistical programming needs of several clinical studies within a development program; the work involves the programming of study and submission-level deliverables and programming vendor oversight for assigned compounds. The position contributes to functional/departmental infrastructure projects.

Essential Job Responsibilities

The primary focus is serving as the lead statistical programmer on clinical studies. The Manager:

  • Is accountable for the production of high quality, on time statistical programming deliverables (such as datasets and tables/listings/figures (TLFs)) for either outsourced or insourced clinical studies. The Manager may be assigned to one or more compounds within a Therapeutic Area (TA), and serves as the single point of contact for assigned studies (for Data Science and Development Operations colleagues). For insourced trials, the Manager directly leads the internal programming team; for outsourced work, the Manager liaises with the lead at the vendor.
  • Provides regular oversight of statistical programming work outsourced to programming Full Service Providers (FSPs) and acts as a liaison between the FSP and the Astellas Biostatistics function. The Manager ensures that the programmed deliverables and their associated timelines, and other requirements around dataset and TLF specifications, program development, and Quality Control are achieved in alignment with Astellas SOPs and other guidelines and conventions.
  • Programs deliverables as needed as well as provides feedback on the statistical deliverables within a study/project/submission. This includes confirming that:
  • Datasets are in compliance with Astellas standards
  • All programming-related files are in the appropriate location on the statistical computing server
  • Submission-based files (for example, SAS transport and define.xml files) are consistent with expectations
  • Software Development Life Cycle forms have been completed
  • Enforces Astellas, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards).
  • Ensures that study-level programmed deliverables are ready to be used in regulatory submissions
  • Actively participates in the development and implementation of programming tools for Statistical Programming infrastructure projects.
  • Is responsible to efficiently communicate, at regular intervals, to functional management on study/project/initiative status and resource issues.

Quantitative Dimensions

Each year, the Manager is involved in four to eight studies within one to four compounds within a TA. The Manager may indirectly provide oversight of zero to eight statistical programmers or FSP resources.

Qualifications

Required

  • Academic degree (bachelor or master in statistics, mathematics, or related field)
  • Four to seven years of relevant programming experience, with at least four years in the pharmaceutical industry and at least two years' experience working with vendors
  • 2+ years' experience as a lead programmer for a clinical study
  • Excellent SAS programming skills (including a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH)
  • Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP etc.)
  • Knowledge of computer system validation methodology and its application in a pharmaceutical environment
  • Excellent team player with excellent communication skills (including English language skills both oral and written)
  • Proven planning and organization skills

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Data Science