Statistical Programming Lead, Safety

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 .

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:

Member of cross-functional teams, the primary purpose of the position is to act independently and contribute to asset level safety activities, 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 asset 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 Lead Safety Programmer (LSP) for one or more asset, supports the Astellas data transparency effort by programming statistical summaries for regulatory-mandated disclosure and represent Astellas on programming matters during inspections.

Under guidance, the position can also support the generation of complex safety TLFs, act as LSP or offer training/mentoring to other programmers.

Essential Job Responsibilities:

For asset level safety programming support:

• Is responsible for the high-quality, on-time development and execution of safety statistical analysis and reporting deliverables (e.g., safety analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)) at the asset level,
• Is a key collaborator with safety statistics in ensuring that specifications are complete and statistical plans are executed efficiently with the right level of validation.
• Is the single point of contact for assigned assets, coordinates the activities of the safety programming team internally, and liaises with the lead programmer at the vendor (as applicable).
  Enforces Astellas, industry and regulatory standards in programmed deliverables (including CDISC standards for safety datasets and internal TLF standards) so that deliverables are ready to be used in ALSAP and regulatory submissions.

Personal development / Collaboration

• 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 research-based sites.
• Is responsible to efficiently communicate, at regular intervals, to Global Programmer Lead (GPROGL) and/or line management on study/project/initiative status and resource issues.

Qualifications:

Required

• Bachelor's or master's in statistics, mathematics, or related field
• 6+ years (9+ years for Bachelor) of experience of relevant programming experience in the pharmaceutical industry and working with vendors
  2+ years' experience as a safety lead programmer for a drug development program

Salary Range

$130K – $170K (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