| Senior Statistical Programmer or Analyst at Remote, Remote, USA |
| Email: [email protected] |
| From: Praveen Kumar, Largeton inc [email protected] Reply to: [email protected] Title- Senior Statistical Programmer/Analyst Location- Remote Duration- 6+ Months Visa- No H1B/opt/cpt ClinChoice is a global CRO supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our customers. ClinChoice was established in the US in 1995, and has grown to more than 3,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website ClinChoice.com for our company information. This is an advanced-level Senior Statistical Programmer/Analyst position. Key responsibilities and skills may include, but are not limited to: must have CRO/FDA experience! Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Analyze information and develop innovative solutions to programming and data analysis challenges. Actively communicate with statisticians for statistical input and analysis interpretation. Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Qualifications Bachelors/Masters degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 years of clinical programming experience. 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. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understanding of clinical drug development process. Strong communication skills and coordination skills. ability to communicate with global teams with supervision. In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understanding of clinical drug development process. Detail-oriented and ability to learn and adapt to changes. Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc. Keywords: cprogramm cplusplus rlang |
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| Tue Feb 06 01:28:00 UTC 2024 |