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 Accovion 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 Selection of the appropriate validation model for developed programs 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 cross functional interaction with other members of the project team Providing internal consultancy in various review activities like database design, data validation rules, statistical analysis plan, 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 Presenting at business conferences and professional meetings 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 members Coordination of internal projects for continuous improvement of processes and systems Project Management External Consultancy Establish and oversee highly complex programming projects Supervisory Responsibilities: N/A Job Requirements: Education BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation Experience Minimum of 8 years experience in processing and analysing clinical trial data or demonstrated aptitude for statistical programming work > 6 years practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation Skills/Competencies Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities) Fluency in English Expert knowledge in SAS In-depth knowledge of relevant regulatory requirements Good knowledge of medical terminology and conduct and analysis of clinical trials Broad knowledge of different indications of clinical trials Knowledge of relevant industry data standards (e.g. CDISC SDTM and ADaM etc.) Ability to conceptualize and optimize project needs Capabilities 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 Project team leadership and project management skills
Principal Statistical Programmer in Bucuresti
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