Statistical Scientist, Oncology (Biostatistics)

Astellas Pharma is a global life sciences company developing transformative therapies, including in oncology. The Statistical Scientist will independently support clinical and observational studies, medical affairs, exploratory and regional statistics, and oncology-related biomarker and PK/PD analyses. The role includes translating scientific questions into statistical deliverables, advising on study design, authoring statistical documents, collaborating with data science teams, and contributing to methodology development.

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

Preferred

• knowledge of R
• R programming

Benefits

• 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.
• 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

Company

• Global life sciences company developing transformative therapies across disease areas.
• Tokyo, Tokyo, JPN
• http://www.astellas.com/
• Founded in 2005
• 10001+ employees

Qualifications

• 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

Required skills

• Biomarker Analysis, Biomedical Research, Biostatistics, Clinical Study Design, Healthcare Technology Assessment (HTA) Analysis, Oncology, Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis, R, SAS, Statistical Analysis Plans, Statistical Methods

Preferred skills

• knowledge of R

Experience

• 3+ years