Associate Biostatistics Director for Biomarkers

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:

The Associate Biostatistics Director acts as fully independent statistician, representing Data Science as a biomarker statistical expert and takes a lead role within Biostatistics on developing and executing project specific biomarker strategies for one or more multiple global projects. This person will combine knowledge of clinical development and to utilize knowledge from clinical biomarkers in clinical trials with a variety of omics data and clinical trial endpoint data into the strategy for progressing development projects.

This is a dual role with involvement in the planning and development of early Phase clinical trials as well as advancing research in the field of biomarkers. Focus will be on biomarker research and will include planning, analysis and communication of data and results. Responsible for providing statistical input to biomarker project development plans, trial designs with focus on biomarkers, accountable for answering questions from regulatory authorities around biomarkers, and outreach to the scientific community.

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 planning and development of early Phase clinical trials in clinical development programs and/or lifecycle management of marketed products

• Provides biomarker strategic statistical input to the project teams and is a major contributor to the project/product level biomarker 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 related to biomarker data and analysis 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 biomarker integrated database(s) where needed, and planning and conduct of integrated biomarker analyses to support development decisions, submissions or marketing needs.

• Represents the company on statistical matters related to biomarker data/analysis 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.

Quantitative 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:

• Reports to Senior Director Exploratory Biostatistics. Closely collaborates with project team members (e.g. project leader, development operations lead, medical lead, HEOR, regulatory affairs, clinical pharmacology, and project management).

• May be 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.

Qualifications:

Required

• MS. or Ph.D. in statistics or equivalent degree/experience

• Minimum of 8 years' experience in applying statistical methods in biomedical research, biomarker data/analysis, extensive pharmaceutical or CRO experience required or demonstrated ability to provide statistical direction in these areas

• Ability to combine knowledge of clinical development and to utilize knowledge from clinical biomarkers in clinical trials with a variety of omics data and clinical trial endpoint data into the strategy for progressing development project.

• Experience in working on clinical project teams and providing statistical expertise in biomarker project development plans. Good understanding of entire drug development process - ability to see the "big picture".

• Experience as the independent statistician in regulatory interactions preferred

• Experience with cross functional process improvement or innovation initiatives

• 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 and knowledge of other statistical software preferred.

• In-depth familiarity with processes and procedures in data management and programming

• Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.

• Ability to work in a matrix environment.

• Proven excellent organizational, project and time management skills.

• Leadership skills and ability to delegate appropriately and provide direction to more junior Biostatisticians.

• Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.

• Very good problem-solving skills.

• Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks

• Ability to perform under pressure

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

• Referral bonus program

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Category Data Science

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans