Astellas Pharma Associate Director Statistical Programming 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 an Associate Director Statistical Programming opportunity in Northbrook, IL.

Position & Scope:

This position directs the statistical programming for one or more Therapeutic Areas (TA) within Statistical Programming; this includes accountability of all programmed deliverables across all clinical development programs and life-cycle management within the particular TA. This position is accountable for the functional management of two to 10 statistical programmers. This position provides input into the Statistical Programming and Data Science strategic objectives and drives implementation of relevant functional objectives.

Essential Job Responsibilities:

The primary focus is to lead the statistical programming effort across one or more Therapeutic Areas. The Associate Director:

  • Is accountable for the production of high-quality, on-time statistical programming deliverables (such as datasets and tables/listings/figures (TLFs)) for all clinical studies within the TA.
  • Will serve as lead statistical programmer for the most complex or high priority clinical development programs; this means the positions will directly lead the internal programming team for insourced work; for outsourced work, the Associate Director liaises with the lead at the vendor.
  • Provides regular oversight of statistical programming work outsourced to Full Service Providers (FSPs) for Statistical Programming, and acts as a liaison between the FSP and the Astellas Biostatistics function.
  • Works with Statistical Programming management peers in devising innovative solutions to common problems which arise in the efficient execution of statistical programs.
  • Supervises two to 10 statistical programmers. This includes recruiting, retaining, and performance coaching.
  • Actively participates in the development and implementation of Statistical Programming and Data Science objectives and contributes to the creation of budget/resourcing models and plans.
  • Enforces Astellas, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards).
  • Ensures that integrated (cross-study) programmed deliverables are ready to be used in regulatory submissions.

Quantitative Dimensions:

The Associate Director leads the statistical programming effort of one or more TAs. The position will be the lead statistical programmer for one to four clinical development programs per year. The Associate Director also directly supervises two to 10 statistical programmers focused on those TAs. Indirectly, the Associate Director provides oversight of 10 to 30 FSP resources.

Organizational Context:

The Associate Director reports to the Director Statistical Programming. There are two to four peers with similar responsibilities.

Required:

  • Academic degree (bachelor or master in statistics, mathematics, or related field)
  • More than 10 years of relevant programming experience, with at least seven years in the pharmaceutical industry and at least two years' experience working with vendors
  • 2+ years' experience as a lead programmer for a drug development program
  • 2+ years of experience in directly supervising statistical programmers
  • At least two years' experience in working on global clinical studies and projects or global process and system initiatives
  • Demonstrated ability to translate strategic plans into goals and objectives
  • Demonstrated leadership skills and ability to effectively prioritize own groups activities for development projects and clinical trials
  • Proven ability create and enforce operating guidelines and procedures
  • 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

Preferred

  • Knowledge of at least one programming language other than SAS (for example SQL, Visual basic, C++)
  • Knowledge of at least one web-development language (for example JAVA, C#, HTML)

*LI-VB

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Data Science