1. Provide leadership support to a study team on all relevant statistical matters by providing planned deliverables.

2. Review case report form (CRF) and provide comments and feedback.

3. Completion of statistical section and integration into study protocol/amendment. CRF that efficiently captures study data and is consistent with data standards.

4 Provide programming team with definitions and documentation for derived variables needed to produce planned tables, figures, and listings (TFLs). Develop data and programming specifications jointly with programmers.

5. Develop statistical analysis plan (SAP).

6. Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, and prepare statistical methods and results sections for the clinical study report (CSR).

7. Perform statistical activities supporting clinical trial randomization, e.g., working with internal and external clients, specification of randomization schemes, and completion of request form.

8. Participate in technology development teams or scientific working groups.

9. Develop SOPs, guidelines, and policies.

10. May fulfill the Lead role for single complex studies or groups of studies.

11. Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies.

12. Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.

13. Perform as project manager to manage customer relationships.

1. Minimum a Masters in Statistics or Biostatistics with minimum 5 years of direct experience working as statistician in clinical trials in the industry (not academia)

2. Work experience at a CRO, a plus strong technical skills (statistical)

3. MUST HAVE excellent communication skills – can interact with others effectively

4. Work well in a team environment

5. Highly organized, detail-oriented, can multi-task and is efficient with their work and time

6. Independent thinker – someone who doesn't have to be watched over constantly, but can get work done

7. Excellent written and oral communication skills including grammatical/technical writing skills

8. Excellent attention and accuracy with details

9. Strong individual initiative, organization skills and multi-tasking ability.

10. Advanced knowledge of CDISC SDTM/ADaM and/or clinical drug development process.