Company:
Katalyst Healthcares & Life Sciences
Location: Boston
Closing Date: 18/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
Lead programming activities and provide input on programming methodologies to support the clinical development process.
Program and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write clear and robust specifications to describe programming needs.
Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
Manage CRO's programming deliverables by reviewing SDTM and ADaM specifications and datasets, and TFL shells and output in collaboration with other Prilenia colleagues.
Ensure the quality of internal and external deliverables consistently complies with analysis and reporting standards and regulatory requirements.
Assist in submission package planning and providing responses to inquiries from global regulatory agencies.
Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
Interact with other internal functions (biostatistics, clinical research and development, regulatory and medical writing).
Requirements:
Graduate degree in statistics, biostatistics, mathematics, computer science, biotechnology, or a related field with at least 7 years (or bachelor's degree with at least 10 years) of SAS programming experience in Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations.
Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) is required.
Clear understanding of the drug development process, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
Ability to effectively communicate and perform in a high demand and dynamic working environment.
Well, organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
Must be able to work under pressure, manage time, set priorities and meet deadlines.
Lead programming activities and provide input on programming methodologies to support the clinical development process.
Program and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write clear and robust specifications to describe programming needs.
Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
Manage CRO's programming deliverables by reviewing SDTM and ADaM specifications and datasets, and TFL shells and output in collaboration with other Prilenia colleagues.
Ensure the quality of internal and external deliverables consistently complies with analysis and reporting standards and regulatory requirements.
Assist in submission package planning and providing responses to inquiries from global regulatory agencies.
Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
Interact with other internal functions (biostatistics, clinical research and development, regulatory and medical writing).
Requirements:
Graduate degree in statistics, biostatistics, mathematics, computer science, biotechnology, or a related field with at least 7 years (or bachelor's degree with at least 10 years) of SAS programming experience in Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations.
Strong knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) is required.
Clear understanding of the drug development process, submission-related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
Ability to effectively communicate and perform in a high demand and dynamic working environment.
Well, organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
Must be able to work under pressure, manage time, set priorities and meet deadlines.
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