Statistical Scientist, Oncology (Biostatistics)

About Astellas

Astellas is a global life sciences company dedicated to transforming innovative science into value for patients. They provide transformative therapies in areas such as oncology, ophthalmology, urology, immunology, and women's health. Through their research and development efforts, they aim to pioneer new healthcare solutions for diseases with significant unmet medical needs.

Purpose & Scope

As a member of cross-functional teams, the primary purpose of the position is to act independently as a Study Statistician/Medical Affairs Statistician (MA)/Exploratory Statistician/Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for routine works in an established area (clinical/observational studies, MA tactics, Biomarker & PK/PD Analyses, or local projects).

The position can also act as a Senior Methodology statistician, independently validating the execution of complex common techniques, offering training/consulting to other statisticians, or researching solutions for novel situations. The position is expected to understand when to seek Global Statistical Lead (GSTATL) and/or line management intervention to ensure successful outcomes with respect to resource requirements or key strategic functional issues.

Under guidance, this position may act as GSTATL or represent the company on statistical matters at meetings with regulatory authorities, key opinion leaders, HTA, or conferences.

Role And Responsibilities

• Contributes to the efficient planning, execution, and reporting of clinical/observational studies, post-hoc analyses, HTA analyses, regional analyses, PK-PD, and Biomarker analyses.
• Translates scientific questions into statistical terms and is responsible for the quality and timeliness of corresponding statistical deliverables.
• Independently provides statistical advice related to study design, selection of endpoints, populations, PK/PD, or biomarkers for routine studies.
• Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Forms, Data Validation Plans, tables listings and figures (TLF) specifications, statistical analyses, clinical study reports, and associated publications (to check the correct interpretation of the data).
• Under the supervision of an experienced statistician, may support more complex studies or asset-level analyses (i.e., integrated summaries, regulatory, payer dossiers, and publications).

Personal Development / Collaboration

• Contributes to cross-functional or indication-level improvement initiatives (i.e., write SOPs, select, validate, and implement statistical software, standard output generation, creation of, maintenance, and adherence to indication-specific standards).
• Collaborates and communicates effectively with other Data Science functions; the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. Close partners with the statistician and programmer, communicating frequently and updating each other and other team members on progress of individual deliverables.
• Develops a reliable network of academics, regulators, and industry peers and investigates and shares new statistical methodologies.

Required Qualifications

• PhD or M.S. in Biostatistics, Statistics, or related scientific field with 3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, academia, or healthcare industry or providing statistical direction in these areas.
• Good knowledge and skills in SAS required, knowledge of R preferred.
• Good understanding of medical literature, clinical, regulatory, and commercial landscapes.
• Prior experience supporting Oncology programs.

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is available. Astellas recognizes the importance of work-life balance and offers a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. They believe this will optimize the most productive work environment for all employees to succeed and deliver.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• Culture of growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Salary Range

$125,090 - $178,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations)

Benefits

• Medical, Dental, and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 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
• Company fleet vehicle for eligible positions
• Referral bonus program