Associate Biostatistics Director

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 Markham, Ontario. 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 :

The Associate Biostatistics Director acts as fully independent global statistical lead, representing Data Science in Core Teams (CMT or Development Core Team).

May be responsible for one or for multiple global or local drug projects. Leads large and / or complex projects, interacts with regulatory authorities (Payers, HTAs, FDA, PMDA, EMA, etc.

and key opinion leaders, supervises other statisticians providing support to the projects and is accountable for the statistical soundness of ALL statistical input and deliverables for the assigned projects.

Provides consultancy to other project teams and other statistical leads in areas of expertise. Is expected to complete these tasks with very minimal supervision, appropriately and pro-actively seeking line management intervention where needed to ensure successful outcome, e.

g. with respect to project resource requirements or key strategic functional issues.

Essential Job Responsibilities :

• Participates in project teams for clinical development programs and / or lifecycle management of marketed products
• Provides strategic statistical input to the project teams and is a major contributor to the project / product level strategy (for example, CDP, CMP, go / no go approach, OCs ).
• Ensures that Data Science needs are reflected within the development plan and strategy across regions.
• Provides statistical advice to study and project teams including design of studies and analyses requiring advanced statistical methodologies.

Recognizes and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value.

• Provides best in class data science support to Astellas drug development programs.
• Ensures quality and consistency of key data science deliverables across studies. Ensures creation of maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results.
• Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
• Represents the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts / bodies
• Reviews key project and study documents to ensure optimal statistical presentation and compliance.

For studies within assigned projects :

• Provides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him / herself.
• Writes or reviews key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports, publications.
• Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, data specifications, TLFs
• Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
• Provides (executive) top line reports of study results

When statistical support or programming for studies or other deliverables within assigned projects are contracted out to a CRO :

• Contributes to vendor selection.
• Performs vendor oversight for assigned programs : Ensures CRO is provided with details, timelines and Astellas specifications and requirements and kept up to date in case of changes.

Monitors timelines, progress and specific issues, and takes action if necessary. Ensures review of the outputs created by the CRO.

Other tasks and roles may include :

Major contributor to cross-departmental / departmental / sectional improvement initiatives, for example : write SOPs; select, validate and implement statistical software;

generate standard output or analysis methods.

• Member or leader of external industry or professional organizations. Develops and maintain relations with leading academic institutions.
• Perform vendor qualification / audits in collaboration with functional management
• Investigates new statistical methodology and feeds back to department and project teams
• Participates in due diligence activities, reviews data and advises company.

Organizational Dimensions :

The Data Science department provides statistical, biometrical and data management / warehousing expertise for all R&D projects and marketed products, encompassing Phase I-IV studies.

Qualified biostatistical expertise for clinical studies and drug submissions is a regulatory requirement and carried out in accordance with international regulations (ICH, FDA, PMDA, EMA) and internal Astellas SOPs and standards.

The results must be reproducible and statistically sound and are subject to internal and external inspections. Flawed statistical input to drug development projects may result in failure to achieve marketing authorization or regulatory approval delays resulting in substantial financial loss for the company.

Undertakes this work with minimal supervision.

Organizational Context :

There are 6 biostatistician levels (excluding functional management roles). This is the fourth level. Reports to Primary Focus Statistics Lead (Executive Director).

Is a member of project teams. Closely collaborates with project team members (e.g. project leader, development operations lead, medical lead, HEOR, regulatory affairs, clinical pharmacology, and project management).

May Lead the data science extended (project) team and deliverables teams, is a member of study teams and / or supervises other statisticians as members of study teams for studies within assigned projects.

Manages to achieve successful outcome through delegation of work, coaches assigned team members within own functions. Provides guidance to / mentors less experienced statisticians.