[Remote] Statistical Scientist, Oncology (Biostatistics)

Note: The job is a remote job and is open to candidates in USA. Astellas Pharma is a global life sciences company focused on innovative therapies for patients. The Statistical Scientist, Oncology (Biostatistics) role supports clinical and observational studies, statistical analyses, and cross-functional decision-making for oncology programs, with responsibilities spanning study design, statistical deliverables, and collaboration with other data science functions.

Responsibilities
• Contributes to the efficient planning, execution and reporting of clinical/observational studies, post hoc analyses, HTA analyses, regional analyses, PK-PD and Biomarkers 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, population, PK/PD or biomarkers for routine studies
• Authors or reviews protocol, statistical analysis plans (Biomarker, PRO, HTA), Care Report Form, Data Validation Plans, tables listings and figure (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 dossier and publications)
• Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards)
• Collaborates and communicates effectively with the other Data Science functions; the position provides Statistical Programmers with study details, timelines, specifications, efficacy analyses algorithms. Close partners, the statistician and programmer communicate frequently and update each other and other team members on progress of individual deliverables
• Is responsible to develop a reliable network of academics, regulators and industry peers as well as investigate and share new statistical methodology

Skills
• PhD or M.S in Biostatistics, Statistics or related scientific field
• 3+ years (6+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
• Good knowledge and skills in SAS required
• Good understanding of medical literature, clinical, regulatory, and commercial landscape
• Ability to understand, implement, and explain complex statistical methodology
• Prior experience supporting Oncology programs
• Knowledge of R preferred

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
• Remote work from anywhere in the US is available
• Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home

Company Overview
• Astellas Pharma develops and commercializes prescription medicines across therapeutic areas. It was founded in 2005, and is headquartered in Tokyo, Tokyo, JPN, with a workforce of 10001+ employees. Its website is http://www.astellas.com.

Company H1B Sponsorship
• Astellas Pharma has a track record of offering H1B sponsorships, with 2 in 2026, 7 in 2025, 4 in 2024, 4 in 2023, 2 in 2022, 3 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.