Astellas Pharma · 3 weeks ago
Statistical Science Lead, Safety Statistician
Northbrook, IL
Full-time
Onsite
Senior Level
$141K/yr - $222K/yr
6+ years expAstellas Pharma is a global pharmaceutical company committed to developing innovative therapies for patients. The Statistical Science Lead will provide safety statistical support for drug development programs and ensure the integrity of safety data science deliverables while leading cross-functional teams and contributing to regulatory submissions.
BiotechnologyHealth CareMedical
Responsibilities
Ensures quality and consistency of key safety data science deliverables
Accountable for the Asset Level Safety Assessment Plan (ALSAP)
For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies
Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose
Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results
Presents summary data and analyses to key stakeholders in a compelling and clear manner
Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs
May participate in due diligence activities, reviews safety data and advises company
Is responsible to implement, explain and validate complex safety statistical methodology
Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value
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 - selection and qualification/audits of vendors)
Contributes to the recruitment, training, professional development and retention of statistical personnel
Is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation
Qualification
Required
PhD or M.S in Biostatistics, Statistics or related scientific field
6+ years (9+ 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
Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical and biomarker data
Knowledge and skills in SAS required
In-depth familiarity with processes and procedures in data management and programming
Experience working in an international environment
Experience in safety data analysis and risk management activities (e.g., ALSAP, DSUR, RMP, signal detection) at the asset level
Good knowledge of medical literature, clinical, regulatory and commercial landscape
Ability to understand, implement, and explain complex statistical methodology
Preferred
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
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase