The Principal Statistical Programmer is responsible for all aspects related to programming activities for the data preparation and analysis of clinical data. Duties include creating all datasets, tables, listings and figures according to the specific project Statistical Analysis Plan (SAP) as well as coordinating Quality Control efforts and implementing all programming required for study/project completion. The Principal Statistical Programmer serves as a project lead and project manager for statistical programming services.
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.
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
Establish and oversee highly complex programming projects
BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation
Minimum of 8 years experience in processing and analyzing 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
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
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
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