Statistical Programmer I
1 week ago
- Our statistical programming team is growing in India, and with big ambitions and a clear vision for the future, now is the time to join Clario
- What we offer:
Competitive compensation-
- Attractive benefits (security, flexibility, support and well-being)-
- Engaging employee programs
- What you'll be doing:
- In the Senior 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 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 we're 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.
- Detailoriented.
- 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 multidisciplinary 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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