Padmi

Senior Statistical Programmer

IndiaPosted 3 months ago
Software engineeringSeniorFull Time; Regular

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Role Overview: You will be responsible for utilizing your strong programming expertise in R Programming to quickly upskill to a proficient level. Your hands-on experience in ADaM dataset creation and TLF programming will be crucial for this role. Additionally, your good understanding of clinical trial data standards and regulatory requirements will enable you to perform data validation, quality checks, and support statistical analysis activities. Your strong analytical, problem-solving, and communication skills will be essential for collaborating with clinical study teams, biostatisticians, and data management teams. Key Responsibilities: - Develop and validate ADaM datasets as per project and regulatory standards. - Generate and validate TLF outputs using R programming. - Support statistical analysis and reporting activities for clinical studies. - Participate in submission activities and assist in addressing reviewer queries. - Collaborate with cross-functional teams to ensure timely and high-quality deliverables. - Follow SOPs, industry standards, and compliance requirements throughout project execution. - Contribute to process improvements and automation initiatives using R programming. Qualification Required: - Strong programming expertise in R Programming. - Hands-on experience in ADaM dataset creation and TLF programming. - Good understanding of clinical trial data standards and regulatory requirements. - Ability to perform data validation, quality checks, and support statistical analysis activities. - Experience working with clinical study teams, biostatisticians, and data management teams. - Strong analytical, problem-solving, and communication skills. Role Overview: You will be responsible for utilizing your strong programming expertise in R Programming to quickly upskill to a proficient level. Your hands-on experience in ADaM dataset creation and TLF programming will be crucial for this role. Additionally, your good understanding of clinical trial data standards and regulatory requirements will enable you to perform data validation, quality checks, and support statistical analysis activities. Your strong analytical, problem-solving, and communication skills will be essential for collaborating with clinical study teams, biostatisticians, and data management teams. Key Responsibilities: - Develop and validate ADaM datasets as per project and regulatory standards. - Generate and validate TLF outputs using R programming. - Support statistical analysis and reporting activities for clinical studies. - Participate in submission activities and assist in addressing reviewer queries. - Collaborate with cross-functional teams to ensure timely and high-quality deliverables. - Follow SOPs, industry standards, and compliance requirements throughout project execution. - Contribute to process improvements and automation initiatives using R programming. Qualification Required: - Strong programming expertise in R Programming. - Hands-on experience in ADaM dataset creation and TLF programming. - Good understanding of clinical trial data standards and regulatory requirements. - Ability to perform data validation, quality checks, and support statistical analysis activities. - Experience working with clinical study teams, biostatisticians, and data management teams. - Strong analytical, problem-solving, and communication skills.

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