Statistical Programmer II
Location: Bangalore, Karnataka (Hybrid)
Department: Service Delivery
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 part of our growth, we are seeking a motivated and detail-oriented Statistical Programmer II to support our mission.
Position Overview:
The Statistical Programmer II provides statistical programming and clinical expertise for the development of SDTM and ADaM domains, tabulations, listings, and graphics from clinical trial data. The role also includes programming Data Management listings, documenting code, performing quality checks, and supporting production and training activities.
Primary Responsibilities:
Data Programming and Support:
Create and validate edit check programs using standard validation practices.
Develop SAS programs to convert EDC data into protocol-specific SAS datasets.
Review and annotate CRFs for SDTM mapping.
Generate ADaM datasets, tables, listings, and figures for safety and efficacy studies.
Work on ISS/ISE studies as needed.
CDISC Standards and Validation:
Apply advanced knowledge of CDISC standards (SDTM & ADaM).
Run P21 reports for SDTM and ADaM, interpret results effectively.
Develop and validate SAS macros as required.
Project Management and Communication:
Manage concurrent activities within a study or project.
Identify and communicate risks proactively.
Participate in SAS-related documentation and macro/format library development.
Quality Assurance and Documentation:
Ensure data quality and integrity in exports.
Review and approve User Requirement Specifications (URS) and CDM documents.
Contribute to the development and enhancement of CDM systems.
Document the creation of CDISC-compliant datasets and related processes.
SAS Environment Support:
Support SAS environment maintenance including installation and updates.
Assist the Study Quality Representative in testing conversion programs.
Timeline and Productivity Management:
Define and adhere to project timeline targets in collaboration with managers.
Communicate any changes in timelines to relevant stakeholders.
Keep leadership informed of project status and challenges.
Efficiency and Training Support:
Coordinate Clinical Programming activities with related departments.
Contribute to procedural evaluations and process improvements.
Support the training team in maintaining and improving training materials.
Secondary Responsibilities:
Contribute to team success through initiative and collaborative support.
Stay updated through company-sponsored training and workshops.
Uphold quality standards by adhering to SOPs and departmental procedures.
Additional Skill Set:
Ability to work independently and collaboratively.
High attention to detail and strong organizational skills.
Strong verbal and written communication skills.
Ability to maintain a professional and positive demeanor.
Education and Experience Required:
Bachelor’s degree in Computer Science or a related field.
Educational background in HCI, UX, applied psychology, or informatics is a plus.
8+ years of SAS programming experience in the pharmaceutical industry – Required.
5+ years working with CDISC, SQL, and relational databases – Required.
3+ years of experience in data extraction and report generation – Required.
Compensation & Benefits:
Competitive salary
Variable pay
Paid time off
Healthcare and retirement benefits
Employment Type:
Full-Time, Permanent
Commitments:
Standard 40 hours/week, Monday–Friday with 1-hour lunch break
Willingness to work in shifts as required
Disclaimer:
Sitero is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other factors prohibited by law.
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