Bioclinica
Location
Bangalore | India
Job description
In the Statistical Programmer role at Clario you will create, test and maintain SAS codes used to create CDISC compliant datasets for the cardiac safety statistical analysis; create and maintain procedures for creation of ADaM datasets and help us create electronic submission packages for cardiac safety submissions.
Support statistical programming activities for assigned Cardiac safety studies - Creation of dataset specifications as per study requirements.
Participate in process improvement for SAS programming and mentoring of new employees.
Perform any and all functions as required to meet corporate commitments and deliverables; in particular, to creating codes for statistical datasets through SAS as well as reviewing and creating the electronic submission deliverables for sponsor submission.
Create and maintain SAS codes for analysis datasets, which includes programming analysis specific flags and other specifications per the Statistical analysis plan.
Create submission ready datasets for cardiac safety trials (SDTM EG and ADaM ADEG) in coordination with the client, internal statistics and data management teams while being compliant with CDISC standards.
Maintain working knowledge of CDISC standards and recommend changes to processes and standard specifications as needed.
Create define.xml and dataset reviewers guide for FDA submissions with reference to the datasets created for statistical analysis. Assist statisticians in preparation of Tables Listings and Figures for cardiac safety studies.
Assist with orientation and training of members of the statistics team, Systems Analysts and Data Management personnel as determined by management.
In conjunction with the entire department, recommend, develop and implement SOPs for improved procedures within the Statistics group.
What were looking for:
BS in computer sciences, Engineering, Statistics or Mathematics.
Experience with CDISC SDTM and ADaM standards.
Minimum of 5 years experience in SAS products and procedures in pharmaceutical or life sciences setting preferred - Understanding of the pharmaceutical drug development process, as gained through a minimum of two years experience in the pharmaceutical or healthcare industry.
Strong organization, analytical and communication skills.
Detail-oriented.
Experience with Windows and Microsoft Office products.
Experience with TFLs generation is a plus.
Ability to work effectively in teams, effectively operates within a matrix organization and with multi-disciplinary groups.
Excellent team player with strong interpersonal skills contributing to building the team spirit.
Ability to understand and anticipate the needs of customers, and respond to their inquiries.
Ability to organize team work and prioritize and balance concurrent tasks and responsibilities.
Excellent time management skills.
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