Statistical Programmer Ii

2 days ago

India Novotech Asia Full time

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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