Senior Statistical Programmers

As a Senior Statistical Programmer at our organization, you will play a crucial role in our Clinical Research team. Your primary responsibility will be to develop, validate, and maintain statistical programs using SAS and R to support clinical trial analysis, reporting, and regulatory submissions. Key Responsibilities: - Develop, validate, and maintain statistical programs using SAS and R for clinical trial data analysis and reporting. - Collaborate with biostatisticians, clinical data managers, and cross-functional teams to understand study requirements and implement statistical analyses. - Create and review derived datasets, tables, listings, and figures (TLFs) in accordance with study protocols and Statistical Analysis Plans (SAPs). - Support regulatory submissions by ensuring compliance with industry standards and regulatory requirements. - Perform quality control and validation of programming outputs to ensure data accuracy and integrity. - Assist in the preparation and review of programming specifications and study documentation. - Ensure adherence to ICH-GCP guidelines and other applicable regulatory standards. - Mentor junior programmers and contribute to process improvement initiatives. Required Skills: - Strong programming experience in SAS and R. - Experience in clinical trial data analysis and reporting. - Understanding of SDTM, ADaM, and TLF development. - Knowledge of Statistical Analysis Plans (SAPs) and clinical study reporting requirements. - Familiarity with clinical data management systems. - Understanding of ICH-GCP and regulatory compliance standards. - Strong analytical, problem-solving, and communication skills. Preferred Skills: - Experience with Python and R Shiny. - Exposure to regulatory submissions and clinical development processes. - Experience working in CRO, pharmaceutical, or biotechnology environments. Qualifications: - Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field. - Advanced degree is a plus. If you join us, you will have the opportunity to work on global clinical research programs in a collaborative and innovative work environment. You will also have access to career growth, professional development opportunities, and exposure to cutting-edge technologies and clinical development practices. Please share your resume with us to express your interest in this role. As a Senior Statistical Programmer at our organization, you will play a crucial role in our Clinical Research team. Your primary responsibility will be to develop, validate, and maintain statistical programs using SAS and R to support clinical trial analysis, reporting, and regulatory submissions. Key Responsibilities: - Develop, validate, and maintain statistical programs using SAS and R for clinical trial data analysis and reporting. - Collaborate with biostatisticians, clinical data managers, and cross-functional teams to understand study requirements and implement statistical analyses. - Create and review derived datasets, tables, listings, and figures (TLFs) in accordance with study protocols and Statistical Analysis Plans (SAPs). - Support regulatory submissions by ensuring compliance with industry standards and regulatory requirements. - Perform quality control and validation of programming outputs to ensure data accuracy and integrity. - Assist in the preparation and review of programming specifications and study documentation. - Ensure adherence to ICH-GCP guidelines and other applicable regulatory standards. - Mentor junior programmers and contribute to process improvement initiatives. Required Skills: - Strong programming experience in SAS and R. - Experience in clinical trial data analysis and reporting. - Understanding of SDTM, ADaM, and TLF development. - Knowledge of Statistical Analysis Plans (SAPs) and clinical study reporting requirements. - Familiarity with clinical data management systems. - Understanding of ICH-GCP and regulatory compliance standards. - Strong analytical, problem-solving, and communication skills. Preferred Skills: - Experience with Python and R Shiny. - Exposure to regulatory submissions and clinical development processes. - Experience working in CRO, pharmaceutical, or biotechnology environments. Qualifications: - Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field. - Advanced degree is a plus. If you join us, you will have the opportunity to work on global clinical research programs in a collaborative and innovative work environment. You will also have access to career growth, professional development opportunities, and exposure to cutting-edge technologies and clinical development practices. Please share your resume with us to express your interest in this role.