Associate Director, Statistics; Statistical Science Lead, Safety

Overview

Statistical Science Lead, Safety Statistician at Astellas Pharma
. This role is based in Northbrook, Illinois, with remote work available for some states in accordance with Astellas’ Responsible Flexibility Guidelines.

Member of cross-functional teams. The Associate Director acts independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex or novel work in safety, clinical, observational studies, MA tactic, Biomarker & PK/PD analyses, or local projects. The position may also act as Global Statistical Lead (GSTATL) for an early or backup asset or as a Methodology expert validating the execution of complex techniques.

Tasks are completed with minimal supervision from GSTATL, LPS, or the Primary Focus Statistics Lead (PFSL). Under supervision of an experienced statistician, this role may lead as global safety statistical lead for a late-phase or novel asset and represent Astellas on statistical matters related to safety data, clinical data, biomarkers, PK/PD, PROs, or methodology at regulatory authority meetings, with key opinion leaders and HTAs.

The position may also research innovative solutions and train other statisticians.

• Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of a study team.
• Ensures quality and consistency of key safety data science deliverables.
• Accountable for the Asset Level Safety Assessment Plan (ALSAP).
• For early or non-complex assets, independently provides strategic safety statistical input to asset teams (e.g., CDP, CMP, go/no go approaches, 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 safety purposes.
• Contributes to regulatory and payer dossiers and publications by providing statistical interpretation of results.
• Presents summary data and analyses to key stakeholders in a clear, compelling manner.
• Ensures availability of safety-related data, biomarker, external data, CRF-integrated databases where needed, and plans and conducts integrated analyses to support development decisions, submissions, or marketing needs.
• May participate in due diligence activities, reviews safety data and advises the company.
• Implements, explains, and validates complex safety statistical methodology.

• Recognizes and addresses issues that may impact the statistical integrity of the development program or where novel statistical methodology may add value.
• Contributes to cross-functional or indication-level improvement initiatives (e.g., SOPs, statistical software selection/validation, standard output generation, indication-specific standards, vendor qualification/audits).
• Contributes to recruitment, training, professional development and retention of statistical personnel.
• Is a member of external industry or professional organizations and collaborates with leading academic institutions to advise internally on innovative statistical methods.

• PhD or MS in Biostatistics, Statistics or related scientific field
• 6+ years (9+ years for MS) of experience applying statistical methods in biomedical research, pharma, CRO, academia, or healthcare, or providing statistical direction in these areas
• Advanced and broad knowledge of statistical methods and industry practices related to clinical and biomarker data analysis
• Knowledge of SAS required; knowledge of R preferred
• Familiarity with data management and programming processes/procedures
• 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,…