Principal Statistical Programmer
Catalyst Clinical Research
📍Remote - Worldwide
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Job highlights
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
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