Purpose & Scope Member of cross-functional teams, the primary purpose of the position is to act independently as 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 tactic, Biomarker & PK/PD Analyses or local project). 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 outcome 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 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).
Personal development / Collaboration
- 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
Required 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, knowledge of R preferred
- Good understanding of medical literature, clinical, regulatory, and commercial landscape
- Ability to understand, implement, and explain complex statistical methodology
- 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.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
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
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