Statistical Programmer/Analyst III - 2
ClinChoice
- Location
- Bengaluru, Karnataka, India
- Job type
- Full-time
Required skills
- Python
- biotechnology
- C++
- communication skills
- database
- Java
- MATLAB
- SAS
- SQL
- statistics
About the role
ClinChoice
Website:
clinchoice.com
Job details:
Responsibilities:
- Analyze data and report statistical results.
- Develop SDTM specifications for programming datasets following CDISC standard.
- Independently develop SAS programs to create SDTM datasets.
- Develop ADaM analysis data specifications for programming following CDISC standard with minimum supervision.
- Independently develop SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan.
- Develop, debug, and maintain SAS programs and macros to create Tables, Listings and Graphs for Clinical Study Report following CDISC, industry guidelines and Statistical Analysis Plan.
- Independently implement SAS programs to generate Define-XML package for FDA submission.
- Develop SAS programmable edit checks to assist data monitoring, document and report data issue to Data Management.
- Implement statistical data analysis and communicate with statisticians for statistical input.
- Support regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities.
- Perform other programming tasks as needed per management requests.
Skills and Qualifications:
- Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 2+ years of statistical programming experience required.
- Proven knowledge and training in high level computing languages such as SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
- Ability to translate statistical analysis plan into SAS programming language, to update and fix existing programs.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Good understanding of clinical drug development process.
- Team player, strong communication skills and coordination skills.
- Detail oriented and ability to learn and adapt to changes.
- Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
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