Director - Biostatistics - Astellas - Northbrook

Job description
Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. In Astellas, a high standard of ethics is mandatory; quality is our pledge; diversity is valued; individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Astellas is actively developing new pharmacological treatments for diseases/disorders in the following therapeutic areas: Oncology, Urology/Nephrology, Immunology/Transplantation, Infectious Disease, Neuroscience and Pain Management. Come, shine with us!Location of the position: Northbrook, IL

Purpose & Scope of Position:

The Associate Biostatistics Director acts as fully independent global statistical lead (GSTATL), representing Global Data Science in Core Teams of drug development. He/she will be responsible for one or multiple new drug development projects.
He/she provides strategic and statistical input to clinical development plans, interacts with regulatory authorities and key opinion leaders, and supervises study statisticians and statistical programmers to ensure adequate statistical support to the projects. He/she is accountable for the statistical soundness of ALL statistical input and deliverables for the assigned projects. Provides consultancy to other project teams and share statistical knowledge and expertise with other GSTATLs. He/she is expected to complete these tasks with very minimal supervision while appropriately and pro-actively sharing information, creating consensus and /or seeking function management intervention where needed to ensure successful outcome.

Essential Job Responsibilities:

Provides strategic statistical input to the project teams and is a major contributor to the clinical development plan (CDP). Ensures CDP with statistical integrity and optimal study designs, and ensures that Data Science needs are reflected within the development plan and strategy across regions.
Provides statistical advice to clinical 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.
Leads the Data Science extended (project) team and deliverables teams. 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
Ensures optimal statistical presentation and compliance and review of key project and study documents. These documents include, but are not limited to, clinical development plans (CDPs), protocols, analysis plans, tables, listings, and figures (TLFs) specifications, study reports, submission documents and correspondence with health authorities.
Provides all required statistical support and deliverables by supervising another statistician in that role, or as a member of study team him/herself.
Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, SDTM/ADaM data specifications, TLFs
Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
Ensure the deliverable of (executive) topline reports of study results
Performs vendor oversight for assigned programs: Ensures CRO provided with details, timelines and Astellas specifications and requirements and kept updated in case of changes. Monitors timelines, progress and specific issues, and takes action if necessary. Ensures review of the outputs created by the CRO

M.S. or Ph.D. in Statistics or equivalent
Minimum of 8 year working experience in applying statistics to drug development at biomedical research, pharmaceutical or CRO
In-depth knowledge in clinical trial designs, data analysis planning, clinical study reports writing required, and knowledge and experience in adaptive designs preferred.
Experience in working on multi-function project teams. Good understanding of entire drug development process - ability to see the "big picture".
Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data and excellent problem solving skills.
Knowledge and skills in SAS required and knowledge of other statistical software preferred.
Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships.
Proven leadership skills to lead and delegate appropriately
Experience in coaching/mentoring junior biostatisticians.
In-depth familiarity with roles and responsibility of Data management and SAS programming
Excellent oral, writing, and presentation skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.
Accurate with a keen eye for detail. Dedication to quality in all work tasks
Ability to perform under pressure

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