Statistical Programmer II
Department: Service Delivery
Location: Bangalore, Karnataka (Hybrid)
Employment Type: Full-Time
Minimum Experience: Experienced
Company Overview:
Sitero is a leading organization specializing in clinical research and healthcare solutions. We are committed to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to expand, we are seeking a highly motivated and detail-oriented Statistical Programmer II to join our team and contribute to our mission.
Position Overview:
The Statistical Programmer II will provide statistical programming and clinical expertise in the production of SDTM and ADaM domains, tabulations, graphics, and listings from clinical trial data. The role also involves programming Data Management listings according to sponsor requirements, ensuring that programming code meets regulatory and company standards, and supporting production activities.
Primary Responsibilities:
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 and ISS/ISE studies.
Possess advanced knowledge in CDISC standards (SDTM & ADaM).
Run P21 reports for both SDTM and ADaM and interpret the results.
Develop and validate SAS MACROs (preferred).
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.
Maintain the SAS environment, including installation, updates, and maintenance.
Review and approve User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents.
Develop and implement enhancements to CDM systems.
Project Management:
Assess and assign target dates for project timelines in collaboration with the manager.
Adhere to target dates and communicate changes proactively.
Keep the department head informed of current issues impacting timelines.
Departmental Contribution:
Coordinate activities with related departments (Operations Programming, Study QA, PM, and DM) to ensure efficiency.
Evaluate and implement improved procedures.
Assist in the development and maintenance of Clinical Programming training materials.
Secondary Responsibilities:
Explore new opportunities to add value to organizational and departmental processes.
Help others achieve results and perform other assigned duties.
Attend and participate in applicable company-sponsored training programs.
Additional Skills:
Ability to work independently and in group settings.
Excellent attention to detail and meticulous work habits.
Strong interpersonal, communication, documentation, and organizational skills.
Ability to maintain a professional and positive attitude.
Education and Experience Required:
Bachelor’s degree in Computer Science, Design, or a related field.
Educational background in HCI, usability, user-centered design, information design, cognitive science, human factors, informatics, or applied sciences is a plus.
8+ years of SAS programming experience in the pharmaceutical industry – Required.
5+ years of experience working with CDISC, SQL, and relational databases – Required.
3+ years of experience understanding database organization and data extraction for listings and reports – Required.
Compensation & Benefits:
Competitive salary and variable pay.
Paid time off, healthcare, and retirement benefits.
Employment Type:
Full-Time, Permanent.
Commitments:
Standard 40 hours per week, Monday–Friday, with one-hour lunch breaks.
Willingness to work additional hours or shifts as needed.
Disclaimer:
Sitero is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status under law.
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