Senior Statistical Programmer

Job Description: As a Clinical Programmer in our team, you will be responsible for developing and validating ADaM datasets as per project and regulatory standards. Your role includes generating and validating TLF outputs using R programming and supporting statistical analysis and reporting activities for clinical studies. Additionally, you will participate in submission activities and assist in addressing reviewer queries. Collaboration with cross-functional teams to ensure timely and high-quality deliverables is a key aspect of this role. It is essential to follow SOPs, industry standards, and compliance requirements throughout project execution. You will also have the opportunity to contribute to process improvements and automation initiatives using R programming. 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 with the ability to upskill to a proficient level quickly. - Hands-on experience in ADaM dataset creation and TLF (Tables, Listings & Figures) 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. Additional Details: Experience in clinical/statistical programming within the pharmaceutical or CRO industry would be preferred. Job Description: As a Clinical Programmer in our team, you will be responsible for developing and validating ADaM datasets as per project and regulatory standards. Your role includes generating and validating TLF outputs using R programming and supporting statistical analysis and reporting activities for clinical studies. Additionally, you will participate in submission activities and assist in addressing reviewer queries. Collaboration with cross-functional teams to ensure timely and high-quality deliverables is a key aspect of this role. It is essential to follow SOPs, industry standards, and compliance requirements throughout project execution. You will also have the opportunity to contribute to process improvements and automation initiatives using R programming. 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 with the ability to upskill to a proficient level quickly. - Hands-on experience in ADaM dataset creation and TLF (Tables, Listings & Figures) 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. Additional Details: Experience in clinical/statistical programming within the pharmaceutical or CRO industry would be preferred.