Senior Statistical Programmer

2 days ago

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Catalyst Clinical Research

WebsiteLinkedInAll Job Openings

Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• The Senior Statistical Programmer is a key member of the Development Operations, Statistical Programming Team. • The Senior Statistical Programmer will program routine and customized data displays, (including listings, tables, and graphics) in accordance with the approved Statistical Analysis Plan and shell displays. • Additionally, the Senior Statistical Programmer will 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. • The Senior Programmer is able to assume a client facing role on multiple projects of mild or moderate complexity, direct and/or mentor programmers at more junior levels and/or participate in department and/or company initiatives. • Creation of safety and efficacy SAS datasets. • Creation of SDTM specifications. • Creation of project specific macros and formats. • 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. • Establish, maintain, and strengthen professional working relationships 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.

Requirements

• A minimum of 5 years SAS programming experience • Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development. • Experience developing custom SAS programs. • Experience with P21 reporting and DEFINE, SDRG, ADRG development. • Creation of annotated CRFs • Previous experience in pharmaceutical research or CRO setting. • Base or Advance SAS certification preferred. • Proficient with Microsoft Office Suite. • Excellent written and oral communication skills. • Excellent presentation skills. • Strong organizational, problem-solving, and analytical skills. • Ability to manage priorities and workflow for self and study teams. • Ability to track, report, and escalate as needed on study level financials and resourcing needs. • Ability to work on a SAS server environment using windows based PC SAS. • Versatility, flexibility, and a willingness to work within constantly changing priorities. • Proven ability to handle multiple projects and meet deadlines. • Strong interpersonal skills. • Ability to deal effectively with a diversity of individuals at all organizational levels. • Commitment to excellence and high standards. • Creative, flexible, and innovative team player. • Ability to work independently and as a member of various teams and committees. • Good judgement with the ability to make timely and sound decisions. • Ability to be discreet with sensitive company information. • Ability to travel for meetings or training activities may be required.