- Leads multiple statistical project teams to provide statistics expertise and capability in support of global development projects and marketed products.
- Oversees all statistics activities to ensure timely and accurate delivery of statistical designs, analyses and reports.
- Independently provides senior statistical expertise in support of regulatory discussions of study/program design, statistical methodology and statistical interpretation of study findings.
- Provides overall strategic planning and technical advisor to the global project/development team for the assigned therapeutic areas.
- Establishes and drives strategy related to resourcing, technologies, processes and standards to maximize efficiency and global data integratability for the assigned therapeutic areas.
- Leads by setting organizational strategies, goals, and priorities aligned with the business needs and strategies of TGRD.
- With support of Senior Director of Statistics and/or VP of Analytical Science, provide statistical strategy for efficient clinical development program for assigned therapeutic areas.
- Supports achievement of major statistical deliverables and milestones in coordination with other functions including Clinical Sciences, Development Operations, Pharmacovigilance, Statistical Programming, Data Management and Medical Writing:
- Feasibility assessment
- Study design, endpoint selection, sample size determination and analysis methodology
- Analysis and reporting plans
- Statistical analysis and reporting outputs
- Cross-study data integration and analysis strategies.
- Interfaces with other Takeda affiliates to create a coherent and globally aligned statistical strategy for the assigned global development projects.
- Provides statistical leadership for regulatory meetings and submissions for the assigned therapeutic areas. Works closely with Regulatory Affairs and Clinical Sciences functions to obtain approvals of New Drug Applications (NDAs), Supplemental New Drug Applications (sNDAs) and Marketing Authorization Applications (MAAs).
- Ensures documentation and archival of statistical deliverables including analysis plans, interim or ad hoc statistical reports, analysis programs, outputs and specifications.
- Provides statistical support to other Takeada functions including Marketing, Medical and Scientific Affairs for activities related marketed products such as marketing strategy, publication plan and health economics and outcomes research.
- With support of Senior Director of Statistics and/or VP of Analytical Science, drives strategy, development and implementation of global systems, processes and standards (including coordination with Europe and Japan) to maximize quality and efficiency of statistical deliverables.
- Standardizes analysis methods and reporting standards to maximize global data integratability.
- Provides access to internal and external statistics expertise and capacity to support assigned clinical and non-clinical development activities:
- Selects, manages and develops staff.
- Manages internal capacity in collaboration with Europe and Japan to effectively support both EU and US studies/programs.
- Effectively leverages external statistics capabilities (vendors and expert consultants).
- Contributes to development of Analytical Sciences vendor strategy and provides oversight of statistical services provided by Analytical Sciences global vendors.
- Plans and manages external budgets related to statistical deliverables. Plans and manages internal administrative budget for the Statistics function as needed.
- Ensures that appropriate training and education programs are in place to develop personnel to help achieve functional goals and long-term strategy.
- Represents function in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
- Ensures compliance of function with Takeda SOPs, standards and all applicable regulations.
Other duties as assigned
EDUCATION, EXPERIENCE AND SKILLS:
- PhD or MS in Statistics or Biostatistics.
- PhD with 10+ years or MS with 15+ years experience in the pharmaceutical industry supporting clinical trials across all phases of development including multiple NDA/CTD and/or MAA submissions.
- 5+ years of progressive management experience.
- Proven track record in identifying and implementing organization-wide initiatives.
- Proven track record in managing global, cross-functional projects.
- 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 Office products).
- In-depth knowledge of statistical design/analysis methodology and reporting procedures utilized in support of clinical trials.
- Active in statistical/pharmaceutical professional organizations including publications and presentations.
- Demonstrated success independently representing Statistics function in interactions with regulatory agencies including FDA (US) and EMEA (EU).
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
- Advanced 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.
- Able to fly to various meetings at investigator, vendor or regulatory agency sites.
- Some international travel may be required.
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.