Manager, Statistics

Uniquely Takeda it's a commitment to helping people worldwide.

At Takeda, we're building our company the right way by putting people first. It's a commitment to the patients we serve and to the employees who share our passion for making a difference. We're working together to improve life worldwide. And we're inviting you to join us.



We have an excellent opportunity for a Manager Statistics at our corporate headquarters in Lincolnshire, IL.



You will perform the following functions in this key role:

Lead and manage team of statisticians to provide expertise and capability specialized by therapeutic area or phase of development.

Oversee all statistics activities for multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses and reports.

Provide senior statistical expertise in support of regulatory discussions of study/program design, statistical methodology and statistical interpretation of study findings.

Establish and drive program-level functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability.

Lead and manage team of statisticians supporting US/EU studies and programs; manage assignments and priorities of team members.

Support achievement of major statistical deliverables and milestones in coordination with other functions including Clinical Research, Safety, Statistical Programming, Data Management and Medical Writing: a) Feasibility assessment; b) Study design, endpoint selection, sample size determination and analysis methodology; c) Randomization; d) Analysis and reporting plans; e) Statistical analysis and reporting outputs; f) Cross-study data integration and analysis strategies.

Provide statistical support for regulatory meetings and submissions.

Work closely with Regulatory Affairs and Clinical Research functions to obtain approvals of New Drug Applications (NDAs), Supplemental New Drug Applications (sNDAs) and Marketing Authorization Applications (MAAs).

Ensure documentation and archival of statistical deliverables including analysis plans, interim or ad hoc statistical reports, analysis programs, outputs and specifications.

Contribute to development of functional strategy and implement global systems, processes and standards to maximize quality and efficiency.

Standardize program-level analysis methods and reporting standards to maximize global data integratability.

Provide access to internal and external statistics expertise and capacity to support development activities: a) Select, manage and develop staff; b) Manage internal capacity in collaboration with US/EU Statistics leadership team in support of both EU and US studies/programs; c) Effectively leverage external statistics capabilities (vendors and expert consultants).

Develop program-level vendor strategies and provide oversight of statistical services provided by BDM global vendors.

Provide input for planning and management of external budgets related to statistical deliverables. Assist in development/management of department administrative budget.

Utilize training and education programs to develop personnel to help achieve functional goals and long-term strategy.

Participate in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and increase the visibility of Takeda.

Ensure compliance of team with Takeda SOPs, standards and all applicable regulations.
REQUIREMENTS


You must possess the following requirements and experience to succeed in this position:

PhD or MS in Statistics or Biostatistics.

Minimum of 6 years experience in the pharmaceutical industry supporting clinical trials across multiple therapeutic areas or development phases.

Demonstrated success in project or task force leadership roles.

Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ products).

In-depth knowledge of statistical design/analysis methodology and reporting procedures utilized in support of clinical trials.

Specialized statistical expertise in multiple therapeutic areas or development phase.

Active in statistical/pharmaceutical professional organizations.

Experience on at least two global projects and at least two NDA/CTDs.

Demonstrated success representing Statistics function in interactions with FDA including end of Phase II or pre-NDA meetings.

Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.

Knowledge of broad drug development process with expertise in the cross-functional interfaces with the Statistics function.

Access to transportation to attend various meetings held in proximity to the Takeda offices.

Ability to drive to or fly to various meetings at investigator, vendor or regulatory agency sites. Some international travel may be required.

Inspiration Required…