Principal Statistical Programmer

1 week ago

Raleigh, United States Catalyst Clinical Research, LLC Full time

As a Principal Statistical Programmer you will be a key member of the Clinical 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, the Principal 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 Principal Programmer 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 Accountabilities/Responsibilities:

  • Creation of safety and efficacy SAS datasets. 

  • Creation 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 and Requirements: 

Education: 

Bachelor’s Degree in Computer Science/Mathematics or equivalent.  MS preferred.

Experience: 

  • A minimum of 7 years of relevant work 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. 

  • Capable of conducting exploratory statistical analyses using statistical software packages. 

  • 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. 

Required Skills:  

  • Proficient with Microsoft Office 365 Suite (Outlook, Excel, Word, PowerPoint, Project preferred). 

  • Excellent verbal, written, and interpersonal skills. 

  • Knowledge of clinical trial study design. 

  • Ability to train staff on company macros and standards and programming approaches used on studies. 

  • Able to work independently on multiple, concurrent projects. 

  • A high degree of accuracy and attention to detail. 

  • Can attend study team meetings as needed. 

  • 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. 

  • 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. 

  • 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. 

Working Conditions:  ​​Sedentary work that primarily involves sitting/standing

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