Senior Statistician - Takeda (Deerfield, IL)

The qualified candidate will provide program-level statistical expertise by designing, analyzing and interpreting clinical studies and programs conducted by TGRD (US and EU), standardize study design, analysis methodology and presentations to maximize global data integration and leveraging external vendors providing statistical services to achieve quality, timely and cost-effective study deliverables.

Responsibilities:

• Represent the statistics function in support of clinical studies led from either the US or EU.
• Provide statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions.
• Provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents.
• Implement project level database (including derived database), analysis and reporting standards.
• Plan and direct study-level analysis and reporting activities including work of other programmers.
• Identify study-level vendor requirements and participate in the evaluation/selection of BDM 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 resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
• Contribute to increasing efficiency of the Statistics function through development of standard analysis methodology, data presentations and sharing of best practices. Support implementation of such standards and process improvements.
• Comply with all applicable regulatory requirements and Takeda standards and procedures. Perform other duties as assigned.

• PhD in statistics or biostatistics with minimum of 2 years of relevant experience or MS in statistics or biostatistics with minimum of 5 years of relevant experience.
• Knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics and data presentation practices.
• Knowledge of the pharmaceutical industry including understanding of clinical drug development process and 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, 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).
• General project management skills.
• Good verbal and written communications skills.

Takeda Pharmaceuticals North America has built a solid foundation on successful products, principles, people, and research. We are working each day to improve the lives of our patients, our community, and our employees and believe we offer a combination of entrepreneurial spirit and proven performance that makes a difference in peoples lives.

TPNA hires experts from diverse fields who are aligned with our company values and possess unique skills that will contribute to the development of our expanding pipeline, R&D capabilities and commercial opportunities. The company culture is one that supports a unique work environment and encourages employees to focus on collaboration, relationships and personal development.

URL: tpna.com/positions.asp#top
Contact Firm: Takeda Pharmaceuticals North America

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