Senior Statistical Programmer

Position OverviewPerforms 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 FunctionsPerform database programming, including derived items, automated edit checks, and customized reportsConduct pre-processing and post-processing of imported and exported dataPerform data quality checks and validationProvide input into and/or assist with:Data management plansStatistical tables, listings, and graph templatesStatistical reportsData review activities through programming supportProduce and deliver:Derived datasets, tables, listings, and figuresPost-processed datasets aligned with CDISC standardsDevelop, maintain, and validate SAS macrosProvide biometrics programming support to internal stakeholders and clientsSupport preparation and review of procedural documents and Trial Master File documentationAny other duties and responsibilities as may be assigned from time to timeKnowledge, Skills, and AbilitiesStrong written and verbal communication skills in EnglishHigh attention to detail and analytical thinkingStrong organizational and planning skillsEffective problem-solving and decision-making abilityProficiency in relevant software tools and ability to learn new systems quicklyStrong interpersonal and collaboration skillsKnowledge of international and local clinical research regulations and guidelinesPosition RequirementsEducation: 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 advantageousPreferences: 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 RequirementsExpected travel time is less than 10% for this position. A valid passport and driver’s license must be maintained at all times.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.