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Parexel logo
Parexel

Parexel is a leading clinical research organization (CRO) providing comprehensive services to the pharmaceutical, biotechnology, and medical device industries. We are committed to advancing clinical research and bringing innovative therapies to patients worldwide. Our diverse team of professionals is dedicated to delivering excellence in regulatory affairs, clinical operations, and data management. Equal Opportunity Statement Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.

Statistical Programmer II

Software EngineerSoftware EngineerFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Mexico

Posted

116 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGCP

Job Description

Statistical Programmer II

Parexel

• Assist in coordinating project start-up activities, including global program creation, tracking spreadsheets, and required documentation. • Continuously check your own work to ensure first-time quality. • Apply efficient programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings of any complexity; perform QC for low–medium complexity datasets, tables, figures, and listings. • Assist in producing and QC’ing derived dataset specifications, process-supporting documents, and submission documentation. • Maintain and expand knowledge of both local and international regulatory requirements within clinical research. • Build expertise in SAS and gain an understanding of processes within other Parexel functional areas. • Provide relevant training and mentorship to colleagues and project teams. • Maintain complete and accurate study documentation according to SOPs/Guidelines to ensure traceability and regulatory compliance. • Ensure compliance with SOPs/Guidelines, ICH-GCP, and other applicable regulations (including 21 CFR Part 11); participate in internal/external audits and regulatory inspections as needed. • Proactively contribute to process and quality improvement initiatives. • Understand regulatory expectations related to industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions).

Job Requirements

  • Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences
  • Excellent analytical skills
  • Intermediate proficiency in the R programming language
  • Knowledge of programming and reporting processes
  • Understanding of SOPs/Guidelines, ICH-GCP, and applicable regulations such as 21 CFR Part 11
  • Ability to learn new systems and work effectively in an evolving technical environment
  • Strong ability to manage competing priorities and adapt to change
  • Proven success working as part of a global team
  • Effective time management to meet daily metrics and team objectives
  • Business and operational skills including customer focus, commitment to quality, and problem-solving
  • Strong understanding of CDISC standards
  • Knowledge of statistical terminology, clinical tests, and protocol designs
  • Excellent attention to detail with a commitment to quality
  • Strong written and verbal English communication skills.

Benefits

  • Exceptional long-term career security
  • Opportunities to work with leading global biopharma and biotech organizations
  • An extensive pipeline of impactful clinical research projects
  • A supportive environment that values work–life balance and professional growth

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