The purpose of this position is to provide study level statistical expertise by:
- Participating in designing and independently analyzing and interpreting data from clinical studies.
- Using standards to maximize global data integratability and interpretability.
- Leveraging internal and external resources to achieve quality, timely and cost-effective study deliverables.
- Represent the statistics function in support of clinical studies, generally supporting multiple studies at a time.
- Provide statistical input to feasibility assessments, development and submission plans, and in support of regulatory submissions.
- Provide statistical support with minimal supervision in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
- Implement project level database (including derived database), analysis and reporting standards. Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at project level.
- Plan and direct study-level analysis and reporting activities (eg, tables, listings, graphs) including review of work by programmers.
- Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
- Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
- Consider and evaluate alternative analysis methodology and data presentation techniques.
- Support development and implementation of departmental standards and process improvements.
EDUCATION, EXPERIENCE AND SKILLS:
- PhD in statistics or biostatistics or equivalent with minimum of 1 year of relevant experience (including internships and statistical researches) or MS in statistics or biostatistics or equivalent with minimum of 3 years of relevant experience.
- Good knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data and presentation practices.
- Good knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
- Knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
- Good knowledge of statistical programming languages (including SAS), software. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products).
- General project management skills.
- Good oral and written communications skills.
- Good collaborative skills and ability to work with a cross-functional team.
- 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.