Senior Biostatistician

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Provide statistical assistance to clinical trials.

• Engage in the development of study protocols, discussions on study design, and calculations for sample sizes.

• Evaluate Case Report Forms (CRFs) and guidelines for data review.

• Create statistical analysis plans, which include specifications for analysis datasets and TLG.

• Conduct statistical analyses and interpret the statistical findings.

• Compose clinical study reports, incorporating integrated summaries for submissions.

• Present and clarify methodologies and the implications of various decisions.

• Comprehend and adhere to FDA regulations concerning clinical trial data reporting, including good clinical practices and electronic submission standards.

• Aid in the development, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.

• Take part in the creation of CRFs, edit check specifications, and plans for data validation.

• Review or draft specifications for data transfers from external vendors.

• Collaborate with both internal and external teams, including CROs, software vendors, and clinical development partners, to achieve project timelines and objectives.

• Review or create Standard Operating Procedures (SOPs) and work instructions pertaining to statistical programming practices.

⛳️ Requirements

• Master’s degree in statistics or a related field.

• A Ph.D. is highly preferred.

• Over 5 years of experience in supporting clinical trials within the Pharmaceutical or Biotechnology sectors.

• Previous experience with a Contract Research Organization (CRO) is highly desired.

• Experience in oncology is a valuable asset.

• Proficiency in sample size calculations, protocol concept and development, SAP, and the preparation of clinical study reports with integrated summaries for submissions.

• Strong SAS programming skills for quality checking critical outputs and working closely with Programmers on Efficacy/Safety tables.

• Familiarity with R programming is advantageous.

• Comprehensive understanding and execution of CDISC requirements for regulatory submissions.

• Skilled in generating ADaM specifications and quality checking datasets.

• Capability to build strong relationships both externally and internally, motivating regional or global teams.

• Strong communication skills, including the ability to explain methodologies and the implications of decisions in layman's terms.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.

• Freedom and ownership while working closely with a pharmaceutical client.