Astellas Pharma US, Inc. Northbrook , IL 60062
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 Senior Statistical Programming Manager opportunity in Northbrook, IL.
Purpose & Scope:
This position is accountable for the statistical programming needs of several clinical studies within one or more development programs; 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. This position also supports the Astellas data transparency effort by programming statistical summaries for regulatory-mandated disclosure and maintaining an environment in which Astellas data is shared with the research community.
Essential Job Responsibilities:
The primary focus is serving as the lead statistical programmer on clinical studies and on submission activities across studies. The Senior 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 and development programs. The Senior Manager may be assigned to one or more compounds within a Therapeutic Area (TA), and serves as the single point of contact for the compound (for Data Science and Development Operations colleagues). The Senior Manager would typically be assigned to critical, complex or high-priority development programs and clinical trials. For insourced trials, the Senior Manager directly leads the internal programming team; for outsourced work, the Senor 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 Senior Manager ensures that the programmed deliverables and their associated timelines, and other requirements around dataset and TLF specifications, program development, Quality Control, and resulting posting 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 and integrated (cross-study) 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.
Leads Statistical programming activities related to the disclosure of Astellas clinical trial data to regulatory agencies and researcher-based sites.
Is responsible to efficiently communicate, at regular intervals, to functional management on study/project/initiative status and resource issues
Each year, the Senior Manager is involved in eight to 12 studies and one to four compounds within a TA. The Senior Manager indirectly provides oversight of eight to 16 statistical programmers or FSP resources.
The Senior Manager reports to an Associate Director Statistical Programming. There are four to eight peers with similar responsibilities.
Academic degree (bachelor or master in statistics, mathematics, or related field)
Seven to 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 leading teams of programmers
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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled