Statistical Programmer Ii
2 weeks ago
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.
**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.
**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 ADaM or analysis datasets specifications for assigned projects.- Undertake peer review ADaM or analysis datasets specifications from junior staff as required.- Program 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.
- Participate in Statistical Programming section meetings, Biostatistics meetings
and Biometrics department meetings.
- Mentor junior staff in technical matters. Software and Programming Tools
- Contribute to developing company programming conventions and SAS macros.
2. **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.
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