Principal Statistical Programmer

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology , a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex . The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com .

As a Principal Statistical Programmer you will be a key member of the Development Operations, Statistical Programming Team. You will program routine and customized data displays, (including listings, tables, and graphics) in accordance with approved Statistical Analysis Plan and shell displays. Additionally, you write CDISC compliant SDTM specifications and program CDISC compliant SDTM and ADaM domains. Code is to be written using SAS, SAS procedures, or standardized macros. You will assume a leadership role on multiple complex projects, direct and / or mentor programmers at more junior levels and / or participate in department and / or company initiatives.

Position Responsibilities / Accountabilities :

• Creation of safety and efficacy SAS datasets.
• Crea tion of SDTM and / or ADaM specifications.
• Creation of project specific macros and formats.
• Creation of CDISC compliant DEFINE, SDRG, ADRG.
• Serve as Statistical Programming subject matter expert (SME) as needed.
• Performing data checks as needed, to ensure integrity and correctness of data displays and to understand structure and content of data.
• Perform QC / validation of datasets, tables, listings, figures to verify the output with high efficiency.
• Establish, maintain, and strengthen professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel.
• Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings / presentations.
• Ensure the quality and integrity of data analysis and reporting.
• Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to management.
• Contribute to the development of functional-level standards, tools, and templates.
• Interact across operational areas as required.
• Interact with sponsor representatives as required.

Position Qualifications / Requirements :

Education :

Experience :

Required Certifications : N / A

Required Skills :

Applicants must be authorized to work for ANY employer in India. We are unable to sponsor or take over sponsorship of an employment visa.

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