Principal Statistical Programmer

Summary

Join our Clinical Development Operations team as a Principal Statistical Programmer! You will play a key role in programming data displays, writing CDISC compliant specifications, and leading complex projects. This position requires extensive SAS programming experience, a strong understanding of clinical trial design, and excellent communication skills. You will mentor junior programmers and contribute to department initiatives. A minimum of 7 years of relevant experience and a Bachelor's degree are required. The ideal candidate will also possess advanced SAS certifications and experience in a pharmaceutical or CRO setting.

Requirements

• Bachelor’s Degree in Computer Science/Mathematics or equivalent
• 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
• 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

Responsibilities

• Create safety and efficacy SAS datasets
• Create SDTM and/or ADaM specifications
• Create project specific macros and formats
• Create CDISC compliant DEFINE, SDRG, ADRG
• Serve as Statistical Programming subject matter expert (SME) as needed
• Perform 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

Preferred Qualifications

• MS preferred
• Base or Advance SAS certification preferred