Company Name:-
Clinipace

Job Location:-
India

Job Summary:-
The Senior 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 project specifications as well as coordinating quality control efforts and implementing all programming required for study/project completion.

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.

Generation and review of dataset specifications
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
Design of integrated databases and development of mapping specifications for integrated datasets
Preparation of electronic submission of clinical data
Intense and cross functional interaction with other members of the project team
Perform all programming work in accordance with the Clinipace SOPs
Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc.

Interaction with clients
Design, developm

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