Principal Statistical Programmer
Company Name:-
Clinipace
Job Location:-
India
Job Summary:-
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 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
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