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Job Description:
Job Overview:
The Statistical Programmer I supports programming activities for the data preparation and analysis of clinical data with low to medium complexity. Duties include creation of datasets, tables, listings and figures according to the project specifications. Work is performed in a team with more senior Statistical Programmers.
Job Duties and Responsibilities:
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.
Support generation of dataset specifications
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
Intense and cross-functional interaction with other members of the project team
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
Supervisory Responsibilities: None
Job Requirements:
Education
BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation
Experience
Entry level position with >2 years’ experience in pharmaceutical and/or CRO environment preferred
Skills/Competencies
Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)
Fluency in English
Working knowledge of the SAS programming language.
Knowledge of relevant regulatory requirements
Knowledge of medical terminology and conduct and analysis of clinical trials
Basic working knowledge of industry data standards (e.g. CDISC SDTM and ADaM)
Capabilities
Team player: Shows
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
