Principal Statistical Programmer
6 days ago
Bachelor's degree from reputable university preferably in
science/ mathematics related fields
- Preferred SAS® certification
Technical Skills
**Requirements**:
- Must have expertise of SAS® Base, and good knowledge of
SAS® graph and SAS® Macros.
- Capable of implementing more advanced statistical
procedures as per specifications provided by biostatistician.
- Must have excellent knowledge of CDISC standards (SDTM
and ADaM)
- Thorough understanding of relational database components
and theory.
- Strong understanding of clinical trial data and extremely
hands on in data manipulations, analysis and reporting of
analysis results.
- Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and
clinical research processes.
Experience requirements
Minimum of 8+ years of experience in Statistical Programming in
pharmaceutical or medical devices industry
Desirable requirements
- Good verbal and written communication skills.
- Ability to work on multiple projects, plan, organize and
prioritize activities.
**Responsibilities**:
At a minimum, following activities are required to be performed;
- Perform all responsibilities associated with the Senior
Programmer role.
- Assist all the Sr. Programmers and Programmers in their
day to day activities.
- Act as escalation point for Sr. Programmer and
Programmer.
- Regularly communicates with the sponsor on the progress
of programming aspects of the project and proactively
anticipates issues and works with the sponsor on resolution
of the problems
- Provide input and/or write the programming specifications
programming
- Understand pharmaceutical industry standards and trends
and proactively plan, develop, and implement
- Develop consistent practices of clinical and statistical
review of output and mentor programming staff
- Check for consistency across therapeutic areas
- Identify, plan, and oversee the implementation and success
measures of all process improvement initiatives
- Maintain expertise in the use of the SAS® Macros and
determine macro development priorities
- Other responsibilities as defined on ad-hoc basis by senior
management.
Relationship & Interactions
- Clinical data manager
- Biostatisticians
- Medical Coders
-
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