Job Description

The Statistical Programmer II is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical Programmers and/or Statistical Programming Management. The SP II works closely with the project biostatisticians and other project stakeholders to plan and assist with leading the development of project-related solutions. The SP II provides support and mentorship to junior programmers.

Responsibilities

1. Projects/Clinical Studies

• Review a clinical study protocol with regards to statistical programming responsibilities.
• Assess study related workload and project timelines and discuss programming time estimates and risk mitigation plans with Statistical Programming Team Lead for inclusion in resource forecasts.
• Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects.
• Undertake peer review of SDTM and ADaM or analysis datasets specifications from junior staff as required.
• Program SDTMs, ADaMs or analysis datasets, tables, figures, and listings (TFLs) according to approved specifications.
• Adhere to company statistical programming standards and conventions, and data standards.
• Ensure that SAS programs generated for data storage, transformation, presentation and statistical analysis are properly documented and traceable.
• Maintain study documentation, programs and files within project files and maintain timesheets.

2. Section

• Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
• Mentor junior staff in technical matters.

3. Software and Programming Tools

• Contribute to developing company programming conventions and SAS macros.

4. Statistical Programming Processes and SOPs

• Ensure compliance with applicable regulatory agency guidelines and Novotech’s corporate policies and SOPs, and SOPs for study design, protocol development and all other statistical programming output.

Minimum Qualifications & Experience

Minimum Master’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.1-year relevant experience required or a bachelor’s degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.2-years of experience in pharmaceutical industry, CRO or related experience using SAS programming in clinical studies. Able to independently perform technical work. Good SAS programming skills. Knowledge of CDISC standards