Senior Statistical Programmer

TOTAL TRIALS INC•Durham, NC
•$90,000 - $125,000

About The Position

The Senior Statistical Programmer performs statistical and database programming for clinical projects, ensuring work aligns with trial protocols, ICH GCP, applicable regulatory requirements, internal procedures, and compliance standards. The role supports high-quality clinical data outputs, data integrity and accuracy, project timelines, and the interpretation and reporting of clinical study results. The position includes programming databases and clinical data, conducting data processing and quality checks, producing datasets and statistical outputs, developing and validating SAS macros, and providing biometrics programming support to internal stakeholders and clients. The programmer also contributes to study planning and reporting documents, data review, and Trial Master File documentation. Flexible hours may be needed to support business needs across multiple time zones. Expected travel is less than 10%.

Requirements

  • Graduate or post-graduate degree in science, biotechnology, or a related field, or an equivalent combination of education and experience.
  • 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.
  • Proficiency in SAS.
  • Availability for flexible hours to support business needs across multiple time zones.
  • Maintain a valid passport and driver’s license.

Nice To Haves

  • At least four years of experience in statistical/database programming within a clinical research setting.
  • Working knowledge of R.
  • Prior experience working in a clinical research setting.

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 or assist with data management plans.
  • Provide input into or assist with statistical tables, listings, and graph templates.
  • Provide input into or assist with statistical reports.
  • Support data review activities through programming.
  • Produce and deliver derived datasets, tables, listings, and figures.
  • Produce and deliver 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.
  • Perform other duties and responsibilities as assigned.
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