About the role
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.
Aplyr's read
ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
What's promising
- •ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
- •The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
- •ClinChoice's global presence allows employees to engage with international projects and clients.
What to watch
- •Limited public information about ClinChoice's workplace culture and employee satisfaction.
- •The company may face competition from larger CROs with more established reputations.
- •Potential candidates might find limited career advancement information publicly available.
Why ClinChoice
- •ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
- •The company has a strong emphasis on statistical programming and regulatory affairs roles.
- •ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.
Aplyr’s read is generated by AI from public sources. Was it useful?
About ClinChoice
ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.
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