Senior Statistical Programmer

TOTAL TRIALS INC; Durham (NC); On-site; USD 90,000 - 125,000; Full time

Job summary

Total Trials, Inc. in the United States is seeking a Senior Statistical Programmer to handle statistical and database programming for clinical projects. You will ensure alignment with trial protocols, ICH GCP, and regulatory requirements, and collaborate across teams to deliver high-quality data outputs.

The role requires experience in SAS, data management, and CDISC standards, with responsibilities spanning Macros, QA, and data review. Flexible hours across time zones may be involved.

Qualifications

• Graduate or post-graduate degree in science, biotechnology, or related field, or equivalent combination of education and experience.
• Minimum of four (4) years' experience in statistical/database programming within a clinical research setting.
• Proficiency in SAS; working knowledge of R is advantageous
• Prior experience in clinical research setting preferred

Responsibilities

• 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: 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

Skills

English communication

Attention to detail

Organizational skills

Problem-solving

Interpersonal skills

Learn new systems

Collaboration

Regulatory knowledge basics

Education

Graduate or post-graduate degree in science/biotechnology

Tools

SAS

R

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Statistical Programmer

Salary Range: $90,000.00 To $125,000.00 Annually

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:
  • 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.