Associate Director, Statistics (Statistical Science Lead, Safety)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS)  for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic,  Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques.  

The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians.

Essential Job Responsibilities:

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 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 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

 Personal Development / Collaboration

• 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.

Qualifications:

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, knowledge of R preferred.
• 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.

Salary Range:

$141,400 – $222,200  (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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