Katalyst CRO
Principal Statistical Programmer
Katalyst CRO - Cambridge, Massachusetts, us, 02140
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Overview
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Principal Statistical Programmer
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Katalyst CRO 5 months ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
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Katalyst CRO Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures. Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs. Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements. Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance. Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications. Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines. Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues.
Responsibilities
Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures. Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs. Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements. Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance. Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications. Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines. Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues.
Requirements:
Bachelor's or master's degree in statistics, biostatistics, computer science, or related field. Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry. Proficiency in SAS programming language, including SAS/Base, SAS/STAT, SAS/MACRO, and SAS/GRAPH. Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA, ICH). Excellent leadership, project management, and communication skills. Proven ability to work effectively in a dynamic, fast-paced environment and manage multiple priorities simultaneously. Experience with programming in R or other statistical software packages is a plus. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
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Principal Statistical Programmer
role at
Katalyst CRO 5 months ago Be among the first 25 applicants Join to apply for the
Principal Statistical Programmer
role at
Katalyst CRO Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures. Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs. Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements. Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance. Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications. Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines. Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues.
Responsibilities
Play a pivotal role in leading statistical programming activities for multiple clinical trials, ensuring the timely and accurate delivery of analysis datasets, tables, listings, and figures. Collaborate closely with cross-functional teams and clients to support the successful execution of clinical development programs. Provide leadership and guidance to the statistical programming team, ensuring adherence to industry standards, best practices, and regulatory requirements. Lead and coordinate statistical programming activities for assigned projects, including timeline management, resource allocation, and deliverable quality assurance. Develop and validate analysis datasets, statistical tables, listings, and figures in accordance with study protocols, statistical analysis plans, and programming specifications. Perform comprehensive quality control checks on programmed deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines. Collaborate effectively with cross-functional teams, including biostatistics, data management, and clinical operations, to address project requirements and resolve programming-related issues.
Requirements:
Bachelor's or master's degree in statistics, biostatistics, computer science, or related field. Minimum of 5 years of experience in statistical programming within the pharmaceutical or biotechnology industry. Proficiency in SAS programming language, including SAS/Base, SAS/STAT, SAS/MACRO, and SAS/GRAPH. Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA, ICH). Excellent leadership, project management, and communication skills. Proven ability to work effectively in a dynamic, fast-paced environment and manage multiple priorities simultaneously. Experience with programming in R or other statistical software packages is a plus. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Statistical Programmer jobs in
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