Senior Biostatistician FSP

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

📋 Description

• Our Senior Biostatisticians conduct statistical analyses to assist with clinical trial and marketed product submissions to regulatory bodies.

• Offer statistical support for clinical studies.

• Engage in the crafting of study protocols, which includes participating in study design discussions and determining sample sizes.

• Review CRFs and data review guidelines; create statistical analysis plans (SAPs), which encompass analysis datasets and TLG specifications.

• Execute statistical analyses and interpret the statistical outcomes.

• Compile clinical study reports, which include integrated summaries for submissions.

• Leverage your strong communication skills to articulate and clarify the methodology and implications of decisions.

• Comprehend and adhere to FDA regulations that influence the reporting of clinical trial data.

• Contribute to the establishment, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.

• Participate in the formulation of CRFs, edit check specifications, and data validation plans.

• Provide reviews and/or author data transfer specifications for external vendor data.

• Collaborate with both internal and external teams to ensure project timelines and objectives are met.

• Review and/or author SOPs and/or Work Instructions pertaining to statistical programming practices.

⛳️ Requirements

• Master’s degree in statistics or a related field; Ph.D. is highly preferred.

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

• Experience with a CRO is highly desirable.

• Background in oncology is an advantage.

• Proficient in sample size calculations, protocol concept and development, SAP creation, and preparation of clinical study reports including integrated summaries for submissions.

• Strong SAS programming skills for quality checking critical outputs, efficacy/safety tables, and working closely with Programmers; knowledge of R programming is a plus.

• Comprehensive understanding and implementation of CDISC standards for regulatory submissions.

• Skilled in generating ADaM specifications and quality checking datasets.

• Ability to build robust relationships with external and internal stakeholders and to motivate a regional or global team.

• Effective communicator, capable of explaining methodology and decision consequences in accessible terms.

🏝️ Benefits

• Our dedication to the development of our staff is only surpassed by our commitment to enhancing treatment options available to patients.

• Cytel strives to foster successful careers and significant professional growth for our employees.