Title:  Statistical Science Lead

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About Astellas 

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. 

Are you driven to make a real difference in the lives of patients? 

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Working Environment and Location

• HYBRID - This position is hybrid and will require you to be onsite one day per quarter in Surrey, Addlestone office.
• 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.

Purpose and Scope

• The primary purpose of this role is to serve as an independent statistical leader within cross functional teams, acting as Study Statistician, Medical Affairs Statistician, Exploratory Statistician, Regional Statistical Lead (RSTATL), or Lead Product Statistician (LPS) for complex or novel work across established clinical development areas. This includes clinical and observational studies, Medical Affairs tactics, biomarker and PK/PD analyses, and regional or local project leadership.
• The role may also function as Global Statistical Lead (GSTATL) for an early stage or backup asset, or as a methodology expert responsible for validating and guiding the execution of advanced statistical techniques.
• This role is targeted at Associate Director or Director level candidates with significant clinical development experience within the pharmaceutical industry, and oncology experience is mandatory.

Role and Responsibilities

• For early or non complex asset, independently provides strategic 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
• 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 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 data and advises company

Continue:Role and Responsibilities

• 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.

Essential Qualifications

• PhD or M.S in Biostatistics, Statistics or related scientific field or related field.
• Substantial years 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
• Good knowledge of medical literature, clinical, regulatory and commercial landscape
• Ability to understand, implement, and explain complex statistical methodology

Benefits

Careers | Astellas

Why Astellas

• We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas and aren't afraid to take intelligent risks. 
• People who act with unwavering integrity and are deeply committed to making a tangible impact. 

Learn more at Astellas.com

Our Organisational Values and Behaviours

Skills and Capabilities

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We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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