Senior Statistical Programmer
Summary
Senior statistical programmer supporting clinical trials at a research services company: builds derived datasets, tables, listings, figures, SAS macros, and automated edit checks aligned with CDISC, ICH GCP, FDA, and EMA standards. Core stack is SAS, with R a plus.
Summary of The Position:
Performs statistical and database programming related to clinical projects. Ensures work is aligned with trial protocols, ICH GCP, and applicable regulatory requirements (including FDA and EMA). Adheres to internal procedural documents and compliance standards. Supports the delivery of high-quality clinical data outputs. Collaborates with cross-functional teams to meet project timelines. Ensures data integrity and accuracy. Contributes to the interpretation and reporting of clinical study results.
Essential Functions:
• Perform database programming, including derived items, automated edit checks, and customized reports
• Conduct pre-processing and post-processing of imported and exported data
• Perform data quality checks and validation
• Provide input into and/or assist with:
- Data management plans
- Statistical tables, listings, and graph templates
- Statistical reports
- Data review activities through programming support
• Produce and deliver:
- Derived datasets, tables, listings, and figures
- Post-processed datasets aligned with CDISC standards
• Develop, maintain, and validate SAS macros
• Provide biometrics programming support to internal stakeholders and clients
• Support preparation and review of procedural documents and Trial Master File documentation
• Any other duties and responsibilities as may be assigned from time to time
Knowledge, Skills, and Abilities:
• Strong written and verbal communication skills in English
• High attention to detail and analytical thinking
• Strong organizational and planning skills
• Effective problem-solving and decision-making ability
• Proficiency in relevant software tools and ability to learn new systems quickly
• Strong interpersonal and collaboration skills
• Knowledge of international and local clinical research regulations and guidelines
Position Requirements
Education: Graduate or post-graduate degree in science, biotechnology, or related field, or equivalent combination of education and experience.
Preferred Job-related Experience: Minimum of four (4) years’ experience in statistical/database programming within a clinical research setting.
Additional Eligibility Qualifications: Proficiency in SAS; working knowledge of R is advantageous
Preferences: Prior experience working in a clinical research setting.
Special Position Requirements: Availability for flexible hours in support of business needs across multiple time zones.
Travel Requirements:
Expected travel time is less than 10% for this position. A valid passport and driver’s license must be maintained at all times.
This job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
Total Trials , Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.