Senior / Project Statistician

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_PLEASE NOTE THAT THE REQUIREMENTS SPECIFIED IN THIS POSTING ARE THE BASIC QUALIFICATIONS REQUIRED FOR THE SENIOR STATISTICIAN POSITION; HOWEVER, JOB TITLE WILL BE DEPENDENT ON THE CANDIDATE\'S LEVEL OF EXPERIENCE IN THOSE REQUIREMENTS._

OBJECTIVE:

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.

ACCOUNTABILITIES:

- 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.