AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group. Our offices are located in France, Belgium, Germany, Czech Republic and India.
Due to fast growth of our company we are currently recruiting a colleague for the position of an Advanced/Senior Statistical Programmer, the position would be based in Pune, India.
Scope of Services :
Services to be provided by the HTA statistical programmers will be in support of project teams delivering analysis and reporting on late stage projects for use in Health Technology Assessment Dossiers. The services will be in statistical programming using SAS on randomized clinical trials relying on the client technologies (for instance, virtual desktop) and processes (for instance, Analysis and Reporting Standard Operating Procedures).
Main responsibilities for this mission consists in updating existing ADaM analysis datasets (based on requirement from statistics) and identified key analysis programs (with creation of Tables, Figures, Listings and a related user guide) as well as developing new project specific ADaM analysis datasets and analysis programs.
Within the framework of programming for clinical, vaccine studies:
1. Participation in project planning
2. Under the responsibility of the Senior SAS Programmer, participate in operational study administration: coordination between study participants
3. Participation in study implementation meetings
4. Based on the statistical analysis plan:
· Drafting of specifications and programming of derived databases
· Assist the biostatistics team when required to programme descriptive statistics tables, figures and listings
5. Validation of patient summary programming
6. Participation in the programming of database mapping
7. Carry out all self-verifications and tests set out in procedures (Good Programming Practices)
Required skills and qualities
- Thoroughness, analytical and deductive skills
- Teamworking skills
- Compliance with commitments
- Strong Clinical Knowledge
- Minimum 4 years of relevant experience in support of analysis and reporting on clinical trials.