Statistical Programmer II

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 Senior Statistical Programmer to join our team and contribute to our mission.

Position Overview

Senior Statistical Programmer will provide statistical programming and clinical expertise in the production of SDTM and AdaM domains, tabulations, graphics and listings from clinical trial data. And also, program the Data Management listings according to the sponsor s requirement. Prepare, document and test required programs and ensure programming code meet regulatory and company standards. Perform quality assurance procedures on work performed by others. Support of production activities, assist in the trainings for new employees.

Primary Responsibilities

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

• Create and validate edit check programs using standard validation practices.
• Develop SAS programs to convert data from EDC to protocol-specific SAS datasets.
• Review and annotate CRFs for SDTM mapping.
• Provide statistical programming support to generate ADaM datasets, tables, listings, and figures for individual studies (both safety and efficacy) and ISS/ISE studies.
• Possess advanced knowledge in CDISC standards (SDTM & ADaM).
• Experience running P21 reports for both SDTM and ADaM and interpreting the results.
• Preferably have experience developing and validating SAS MACRO.
• Ability to proactively manage concurrent activities within a study or project.
• Communicate and escalate risks within assigned studies or projects.
• Assist with the creation of SAS-related project programming and validation documentation.
• Assist with the creation of SAS macro and format libraries.
• Ensure the quality of our clients data and data export.
• Review and approve User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents.
• Develop and implement 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 testing protocol-specific SAS conversion programs.

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

• Assess and assign target dates for project timelines in collaboration with the manager.
• Adhere to target dates for project timelines.
• Communicate any changes in target dates to the appropriate personnel, including the Project Manager.
• Keep the department head informed of current issues.

Maintain departmental productivity and identify opportunities for greater efficiency and quality by:

• Coordinating activities of the Clinical Programming department with related departments (operations programming, study QA, PM, and DM) to ensure efficiency.
• Evaluating current procedures and work instructions 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

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

EDUCATION AND EXPERIENCE REQUIRED

• Bachelor s degree in computer science, design or related field required
• Educational background in human-computer interaction, 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.

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

COMPENSATION & BENEFITS

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE

Full Time, Permanent

COMMITMENTS

Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.

Willing to work in shifts as and when needed.

DISCLAIMER

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.