1. Follow established standards and procedures to perform the programming, testing, validation, and documentation (including specifications) of (a) statistical programs for use in creating statistical summary tables, figures, and listings; (b) CDISC SDTM; (c) ADaM datasets (analysis datasets); (d) the integration of databases from multiple studies or sources.

2. Perform programming of database quality control checks and data cutoff.

3. Review and validate SDTM datasets including specifications, ADaM datasets including specifications and TFL outputs and provide comments.

4. Participate in ad-hoc analysis.

5. Perform, plan and coordinate the development, implementation and validation of new process technologies, macros and applications.

6. Use Pinnacle 21 and other tools to correct deviations and may assist reviewing reports.

7. Design and review Patient Profile.

8. May assist in leading support for DSMB, regulatory meetings and publications, and NDA submissions.

9. Work independently, as while as being a team member working with other statistical analysts and statisticians.

10. Perform other duties as directed by management or senior personnel.

1. BS degree in statistics, computer science, life science, mathematics or related field with 3+ years of relevant work experience.

2. Credits in elementary statistics courses are desired.

3. Expert knowledge of Base SAS and advanced knowledge of  SAS modules/Macro language are required.

4. Familiar with the usage of different statistical methods.

5. Excellent organizational, interpersonal, and communication skills are essential.

6. Advanced knowledge of GCP, ICH and Regulatory guidelines, CDISC SDTM/ADaM and/or clinical trial process.