Lead Statistical Programmer

Company Overview

Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission.

Position Overview

The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with sponsor requirements, preparing, documenting and testing necessary programs and ensuring that programming code adheres to regulatory and company standards. The role also involves performing quality assurance on work done by others, supporting production activities and assisting in training new employees.

Primary Responsibilities

Provides data to clients (internal and external) in functional format by:

• Creating and executing SAS edit check programs
• Validating edit check programs using standard validation practices and processes
• Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications
• Assist with the creation of SAS-related project programming and validation documentation
• Assist with the creation of SAS macro and format libraries

Ensures the quality of our client's data and data export by

• Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents
• Developing and implementing new CDM systems and enhancements to current CDM systems
• Understand, create, and communicate information about creating CDISC-compliant datasets
• Create documentation related to the generation of customer specific SAS datasets
• Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance
• Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs

Ensures project timelines as they relate to Clinical Data Management operations by

• Assessing and assigning target dates for project timelines in conjunction with manager
• Adhering to target dates for project timelines
• Communicating any changes in target date to appropriate personnel including
• Project Manager Keeping department head informed of current issues
• Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by:
• Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency
• Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures
• Assisting the training department with the development and maintenance of Clinical Programming training materials

Secondary Responsibilities

Contributes to team effort by

• Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary

Maintains Technical Knowledge by

• Attending and participating in applicable company sponsored training

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives

Qualifications

Education

• Bachelors degree in computer science, design or related field required
• Educational background in human-computer nteraction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus.

Experience

• 8+ Years of experience, SAS programming experience in pharmaceutical related industry - Required
• 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases - Required
• 3+ Years of experience, Understanding of database organization and how to extract data to generate listings and reports - Required

Additional skill set

• Ability to work in group setting and independently; ability to adjust to changing priorities
• Excellent attention to detail and orientation toward meticulous work
• Strong interpersonal and communication skills, both verbal and written
• Strong documentation and organizational skills
• Ability to project and maintain a professional and positive attitude

Working conditions

Travel: 5-20%

Lifting: 0-25 lbs

Other: Computer work for long periods of time

THIS POSITION DESCRIPTION SHOULD NOT BE DEEMED ALL INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.