Senior Statistical Programmer
Brief description :
Senior Statistical Programmer (exp minimum 5 years) No of openings -3
- Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data, e.g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards and standard operating procedures issued by Clinipace and/or clients as appropriate.
- Conception and generation of dataset specifications
- Design of integrated databases and development of mapping specifications for integrated datasets
- Development and documentation of programs used to generate datasets
- Development and documentation of programs used to generate listings, tables and graphs
- Program validation including generation of validation documentation
- Data preparation and documentation according to CDISC data standards
- Preparation of electronic submission of clinical data
- Intense and crossfunctional interaction with other members of the project team
- Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc.
- Interaction with clients
- Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied
- Writing of User Manuals
- Training of group members on new processes, programs etc. as appropriate
- Initial Training on existing processes, programs etc. for new group members
- Attending and representing the company at business conferences
- Participation in industry working groups
- Coordination of allocated teams of Statistical Programmers assigned to a specific client project including the monitoring of workload, estimation and forecast of resource needs within the specific activity and responsibility for coaching and education of other team membersCoordination of internal projects for continuous improvement of processes and systems
- Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)
- Fluency in English
- Expert knowledge in SAS
- Knowledge of relevant regulatory requirements
- Knowledge of medical terminology and conduct and analysis of clinical trials
- Knowledge of different indications of clinical trials
- Knowledge of industry data standards (e.g. CDISC SDTM and ADaM)
- Team player: Shows support for teamwork, cooperation, self-control, and flexibility to get the job done.
- Comfortable working under supervision and as part of a team.
- Practices professionalism and integrity in all actions.
- Demonstrates honesty, trust and fairness.
- Strong written and verbal communication skills