Clinical Outcomes Solutions
Clinical Outcomes Solutions
Clinical Outcomes Solutions is a global consultancy focused on clinical outcome assessment (COA) research for pharmaceutical and biotechnology organizations. Its team develops research strategies and practical solutions for capturing reliable data about patients’ experiences, helping clients address the scientific and regulatory complexities of clinical outcomes work. By bringing the patient voice into research design and evidence generation, the company supports informed care decisions and stronger patient outcomes.

Senior Biostatistician – Clinical Trials, Colombia Remote

Support Phase I–IV clinical trials and regulatory submissions for pharmaceutical clients. Develop statistical analysis plans, analyze clinical data, and prepare integrated clinical study reports.

Description

  • Deliver statistical support across clinical studies
  • Contribute to protocol development, study design decisions, and sample size calculations
  • Review case report forms and data review guidelines
  • Create statistical analysis plans with analysis dataset and TLG specifications
  • Conduct statistical analyses and interpret the resulting findings
  • Draft clinical study reports and integrated submission summaries
  • Explain statistical methods and the implications of analytical decisions
  • Apply FDA requirements for clinical trial data reporting, good clinical practice, and electronic submissions
  • Help establish, document, maintain, and validate standards for programming tools, outputs, and macros
  • Support development of case report forms, edit check specifications, and data validation plans
  • Review or prepare data transfer specifications for external vendor data
  • Coordinate with internal and external teams, including CROs, software vendors, and clinical development partners, to deliver project goals on schedule
  • Review or prepare SOPs and work instructions for statistical programming practices

Requirements

  • Master’s degree in statistics or a related field
  • A Ph.D. is strongly preferred
  • At least five years of clinical trial experience in the pharmaceutical or biotechnology industry
  • CRO experience is strongly preferred
  • Oncology experience is advantageous
  • Experience with sample size calculations, protocol concept and development, statistical analysis plans, and clinical study reports with integrated submission summaries
  • Strong SAS programming skills for quality control of critical outputs and efficacy and safety tables, with the ability to collaborate closely with programmers
  • R programming experience is advantageous
  • Strong knowledge of CDISC requirements for regulatory submissions
  • Proficiency in generating ADaM specifications and performing dataset quality control
  • Ability to build effective internal and external relationships and motivate regional or global teams
  • Clear communication skills, including the ability to explain statistical methods and decision impacts in accessible language

Benefits

  • Ongoing training, development, and professional support
  • Strong opportunities for career growth
  • Autonomy and ownership while embedded with a pharmaceutical client

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