Astellas Pharma Manager/Sr. Manager, Statistical Programming (PK/PD) in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
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 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.
Each year, the Manager is involved in four to eight studies within one to four compounds. The Manager may indirectly provide oversight of zero to eight statistical programmers or FSP resources.
The Manager reports to an Associate Director Statistical Programming or director. There may be four to eight peers with similar responsibilities.
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, PMDA, ICH- GCP etc.)
Knowledge of computer system validation methodology and its application in a pharmaceutical environment
Excellent team player with excellent communication skills
Proven planning and organization skills
Experience with PK/PD data is required; R programming experience is desirable.
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
401(k) Match and Annual Company Contribution
Company Paid Life Insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Data Science
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans