"Alerted.org

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 and Scope:

As a senior level programmer, the primary purpose of the position, is to act independently and lead programming work for clinical studies or Medical Affairs studies, Exploratory/Regional work supporting complex/novel work within a development program (clinical/observational studies, MA tactic, PK/PD and Biomarker analyses or regional project). This includes global accountability of all programmed deliverables at the study and submission level within assigned programs in one or more Primary Focus (PF) areas. In addition, the position is responsible for programming vendor oversight for assigned compounds and contributes to functional/departmental infrastructure projects.

The position acts independently as Global Programmer Lead (GPROGL) for a late stage / complex asset and represents Astellas on programming matters during inspections. The position is assigned to the most complex tasks, offers training/mentoring to other programmers and leads assigned Quantitative Sciences and Evidence Generation (QSEG) strategic objectives and drives implementation of relevant functional objectives.

Essential Job Responsibilities:

For complex tasks, the span of which ranges from individual late phase clinical trials to world-wide regulatory application submissions, HTA submissions and post marketing support.

+ Is responsible for the production of high-quality, on-time statistical programming deliverables (such as datasets and tables/listings/figures (TLFs)). Ensures that integrated programmed deliverables are ready to be used in regulatory submissions and follow Astellas, industry and regulatory standards.

+ Is accountable for the efficient use and oversight of programming vendors.

+ Directly leads the internal programming team for insourced work; for outsourced work, the position liaises with the lead at the vendor.

+ Provides regular oversight of statistical programming work outsourced to Full-Service Providers (FSPs) and acting as a liaison between the FSP and Astellas.

Personal development / Collaboration

+ Recognizes and addresses issues which may impact the validity, or completeness of the deliverables

+ Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - implement novel statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards).

+ Works with peers in devising innovative solutions to common problems which arise in the efficient execution of statistical programs.

+ Contributes to the recruitment, training, professional development, and retention of statistical programming personnel.

+ Is a member of external industry or professional organizations.

Qualifications:

Required

+ Bachelor’s or master’s in statistics, mathematics, or related field

+ 9+ years (12+ years for Bachelor) of experience of relevant programming experience in the pharmaceutical industry and working with vendors

+ 5+ years’ experience as a lead programmer for a drug development program

+ 2+ years’ experience in mentoring/leading statistical programmers

Salary Range

$150K – $195K (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

\#LI-SS

Category Quantitative Sciences & Evidence Generation

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans