Statistician Iii, India

Overview:
Work as a statistician on clinical trials; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Working within a reporting team environment, being responsible for assigned statistical and programming aspects of reporting out study results. Excellent team work ethos, and willingness to help others.

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

- Program, validate and QC datasets including SDTMs and complex datasets, e.g. ADQS, ADLB
- Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation ,
- Create and validate simple dataset specifications for single studies
- Write study level SAP text copying from a similar study or amending a standard template
- Create project level shells, ensuring templates and standards are adhered to
- Simple clinical study under supervision
- Manage day-to-day workload to ensure project deliverables are met
- Awareness of CDISC standards
- Perform sample size calculation for any study
- Perform simple simulations with supervision
- Create actual randomisation schemes
- Work as part of the team producing unblinded outputs
- Cross-check results in CSR vs final outputs
- Archive own study documentation following instructions in supplied SOPs
- Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work
- Implement Good Clinical Practice and adhere to regulatory requirements at all times
- Work in a team for furthering statistical research
- Assist in development of internal training courses
- Being responsible for statistical aspects of deliverables for non-complex deliveries with supervision

Qualifications:

- PhD or MSc in Biostatistics or related discipline
- Some knowledge of the pharmaceutical industry with an awareness of clinical trial issues. Familiarity with GCP and regulatory requirements.