Programmer Iii

3 weeks ago

Remote, India PHASTAR Full time

Overview:
Work as a programmer on clinical and non-clinical trials; producing non-complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Awareness of CDISC SDTM and ADaM implementation guidelines; reviewing and updating non-efficacy/non-complex data specifications; creating and debugging simple macros; understanding Statistical Analysis Plans (SAPs) and output shells for day to day programming activities. Excellent team work ethos, willingness to help others and learn new skills from working in a team environment.

**Responsibilities**:
Employees may be required to perform some or all of the following:

- Program complex non efficacy datasets
- Program complex non efficacy outputs/ figures
- Develop and debug more complex macros
- Create, QC and update simple, non-efficacy dataset specifications for single studies
- Review simple study design SAP with supervision
- Review listings and simple summary shells without supervision and provide feedback
- Awareness of CDISC SDTM and ADaM implementation guidelines
- Creation of CRT packages as part of the team. Understand FDA requirement
- Become familiar with and follow study documentation
- Work as part of a team with the aim of furthering programming development
- Ensure the principles in the PHASTAR checklist are followed rigorously
- Archive own study documentation following instructions in supplied SOPs
- Lead a part of the study for single study

Qualifications:

- Bachelors or above within Computer Science, Mathematics or a Science related discipline
- SAS Programming Experience within the pharmaceutical industry
- Good awareness of clinical trial issues, design, and implementation.
- Familiarity with GCP and regulatory requirements
- Experience of programming to SDTM and ADaM standards

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