1) Perform validation of clinical reports including tables, listings, graphs, and patient profiles developed by statistical programming staff.
2) Validate the statistical models and methods proposed for conducting statistical analysis on clinical trial data.
3) Develop the analysis specifications for projects involving pooling of data from multiple clinical trials.
4) Review and provide input in design of case report forms, development of statistical analysis plan, and data management plans. Review and approve programming specifications developed by programming staff.
5) Provide oversight and monitoring on programming project deliverables and ensure that the staff follows necessary processes while executing the project.
6) Ensure that each statistical reporting deliverable has necessary and sufficient documentation as required from customer specific SOPs and processes.
7) Act as a point of contact from the division to address any customer concerns and work on investigating the quality issues.
8) Act as a liaison between the upper management and project teams and communicate the quality issues in a timely manner.
9) Write statistical reports, develop statistical analysis plans and work as a point of contact in project specific meetings.
1) Masters degree in Biostatistics, Statistics, or Mathematics.
2) At least 5 to 7 years of experience in biostatistical and data reporting with a focus on analysis and reporting of clinical data.
3) Experience with statistical methodologies, and data validation, and mining techniques.
4) Strong knowledge and experience of various clinical trial designs.
5) Thorough understanding of clinical data models and safety and efficacy domains in clinical trials.
6) Prior experience in therapeutic areas of Oncology, Inflammation, Infectious Disease, and CNS is strongly preferred.
7) Thorough understanding of the drug development process, clinical trial reporting processes, and experience of data component of drug submission is a plus.
8) Good understanding of ICH guidelines, Good Clinical Practices (GCPs), and 21 CFR part 11 as these relate to the statistical reporting. Prior experience of drug submission or representation in meetings with regulatory authorities is strongly preferred.
9) Strong experience of safety and efficacy reporting. Understanding of clinical data life cycle from data collection to submission.
10) Understanding, knowledge and experience of CDISC data standards and models.
11) Excellent communication, time management, and problem solving skills.
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