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Principal Statistical Programmer

2 months ago


Raleigh, North Carolina, United States Catalyst Clinical Research, LLC Full time

{"Job Title": "Principal Statistical Programmer", "Job Summary": "We are seeking a highly skilled Principal Statistical Programmer to join our Clinical Development Operations, Statistical Programming Team. As a key member of the team, you will be responsible for programming routine and customized data displays, including listings, tables, and graphics, in accordance with approved Statistical Analysis Plan and shell displays. Code will be written using SAS, SAS procedures, or standardized macros. You may assume a leadership role on a project, direct and/or mentor programmers at more junior levels, and/or participate in department and/or company initiatives.

**Key Responsibilities:**

* Creation of safety and efficacy SAS datasets
* 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
* Performing QC/validation of datasets, tables, listings, figures to verify the output
* Establishing, maintaining, and strengthening a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendors, and subcontract personnel
* Representing the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations
* Ensuring the quality and integrity of data analysis and reporting
* Maintaining awareness of project budgets and tasks, and effectively communicating the status of such tasks to management
* Contributing to the development of functional-level standards, tools, and templates
* Interacting across operational areas as required
* Interacting with sponsor representatives as required

**Qualifications and Requirements:**

* Bachelor's Degree in Computer Science/Mathematics or equivalent. MS preferred
* Hands-on experience with CDISC/SDTM/ADaM programming
* A minimum of 5 years SAS programming experience
* Previous experience in a pharmaceutical research or CRO setting
* 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
* 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 judgment with the ability to make timely and sound decisions
* Ability to be discrete with sensitive company information
* Knowledge of clinical trial study design
* Ability to attend study meetings as needed

**Working Conditions:**

Sedentary work that primarily involves sitting/standing