Description
- 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.
- 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.
- Support development and implementation of departmental standards and process improvements.
EDUCATION
- PhD in statistics or biostatistics or equivalent with minimum of 2 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics or equivalent with minimum of 4 years of relevant pharmaceutical industry experience.
- Good knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics
- 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.
- General project management skills.
If you would be interested this opportunity then please get in touch with Oliver Davies at Real Staffing on or visit https://www.linkedin.com/profile/public-profile-settings?trk=prof-edit-edit-public_profile for further details.