Responsibilities: * Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. * Be responsible for overall project delivery, including clinical trial ...
Katalyst
20 jobs near Raleigh, NC
Responsibilities: * Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. * Be responsible for overall project delivery, including clinical trial ...
Support 1, Operations Intern
$15.25 - $19.75/hr
* The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...
Support 1, Operations Intern
$15.25 - $19.75/hr
* The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...
Responsibilities: * Review and ensure accurate and high-quality statistical programming deliverables from CRO. * Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance ...
Responsibilities: * Review and ensure accurate and high-quality statistical programming deliverables from CRO. * Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance ...
Quality Engineer ( Medical Devices )
$70.70K - $91.40K/yr
Quality Engineer (Contract) Location: Apex, NC (primary responsibilities) * Conducting product and process audits to identify areas for improvement * Developing and implementing quality control plans ...
Quality Engineer ( Medical Devices )
$70.70K - $91.40K/yr
Quality Engineer (Contract) Location: Apex, NC (primary responsibilities) * Conducting product and process audits to identify areas for improvement * Developing and implementing quality control plans ...
Responsibilities: * Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. * Develop and manage data management timelines for ...
Responsibilities: * Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. * Develop and manage data management timelines for ...
Responsibilities: * In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ...
Responsibilities: * In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ...
* The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP (Clean-In-Place) systems supporting Drug ...
* The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP (Clean-In-Place) systems supporting Drug ...
Responsibilities: The Associate Inventory Analyst will support our continuous improvement and operational excellence goals by performing regular inventory counts and system analysis to identify ...
Responsibilities: The Associate Inventory Analyst will support our continuous improvement and operational excellence goals by performing regular inventory counts and system analysis to identify ...
Engineering Intern
$14 - $18/hr
* The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...
Engineering Intern
$14 - $18/hr
* The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...
Assembler 1, General
$14 - $16.25/hr
Responsibilities * Perform a wide range of production processes including but not limited to wiring, component, installation, cable assembly, and the assembly of complete units. * Assembles ...
Assembler 1, General
$14 - $16.25/hr
Responsibilities * Perform a wide range of production processes including but not limited to wiring, component, installation, cable assembly, and the assembly of complete units. * Assembles ...
Senior Process Engineer
$100.30K - $129.70K/yr
Summary: * Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at our Holly Springs site. This role is fully onsite and ...
Senior Process Engineer
$100.30K - $129.70K/yr
Summary: * Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at our Holly Springs site. This role is fully onsite and ...
Responsibilities: * Review protocols for CDISC conformance. * Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. * Write and manage SAS code for mapping clinical data ...
Responsibilities: * Review protocols for CDISC conformance. * Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. * Write and manage SAS code for mapping clinical data ...
Responsibilities: * Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. * Author validation plans, verification reports, and ...
Responsibilities: * Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. * Author validation plans, verification reports, and ...
Responsibilities: * Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic ...
Responsibilities: * Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic ...
Support 1, Operations Intern
$13.75 - $18/hr
The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...
Support 1, Operations Intern
$13.75 - $18/hr
The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring ...
Responsibilities: * Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development, market access, and ...
Responsibilities: * Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development, market access, and ...
Summary: This role involves solid, hands-on CSV work in a regulated environment where good documentation, accountability, and clear communication are essential. Responsibilities: * Evaluating ...
Summary: This role involves solid, hands-on CSV work in a regulated environment where good documentation, accountability, and clear communication are essential. Responsibilities: * Evaluating ...
Roles & Responsibilities: * Support implementation of a new MES for drug substance manufacturing operations. * Contribute across multiple phases including electronic equipment tracking, electronic ...
Roles & Responsibilities: * Support implementation of a new MES for drug substance manufacturing operations. * Contribute across multiple phases including electronic equipment tracking, electronic ...
Responsibilities: * Support the Senior Director in developing and executing regional regulatory strategies for QOL * initiatives within specific regions. * Contribute to providing strategic oversight ...
Responsibilities: * Support the Senior Director in developing and executing regional regulatory strategies for QOL * initiatives within specific regions. * Contribute to providing strategic oversight ...
Responsibilities: * Execute comprehensive verification of digital infrastructure and automated platforms. * Generate technical specifications and operational flowcharts alongside hazard evaluations.
Responsibilities: * Execute comprehensive verification of digital infrastructure and automated platforms. * Generate technical specifications and operational flowcharts alongside hazard evaluations.
Job description
Responsibilities:
- Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
- Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.
- Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
- Assist in establishing standardized programming procedures and work instructions.
- Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities.
- Develop and maintain clinical processing workflow systems.
- Assist in the development of client proposal documents.
- Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
- Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.
- Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.
- Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g., Chapter 21 of the US Code of Federal Regulation - Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards).
- Assist in updating/writing PROMETRIKA standard operating procedures (SOPs).
- Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
- Develop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
- Create define.xml files from metadata files for SDTM and ADaM.
- Convert data received in other formats to SAS datasets.
- Must have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.
- Knowledge of SDTM, ADaM, FDA and ICH guidance.
- Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems.
- Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.
- Consistent experience as a lead statistical programmer on several concurrent projects.
- Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
- Strong mentoring skills as shown by leadership of projects and if applicable, junior team members.
- Excellent analytical skills.
- Proven ability to learn new systems and function in an evolving technical environment.
- Ability to negotiate and influence to achieve results.
- Good presentation skills.
- Good business awareness/business development skills (including financial awareness).
- Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
- Work effectively in a quality-focused environment.
- Knowledge of other programming languages and database management software packages is a plus.