Senior/Principal Statistical Programmer FSP

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

📋 Description

• Fully integrated within one of our pharmaceutical clients, with Cytel's support firmly behind you.

• The Principal Statistical Programmer operates autonomously, following only high-level instructions and requiring minimal supervision, while tracking progress and offering expert technical assistance to team members.

• Responsible for executing all reporting and analytical activities for the Sponsor's clinical trials.

• Involved in supervising CRO programmers to ensure that data summaries are consistently delivered with high quality.

⛳️ Requirements

• A minimum of a bachelor’s degree in computer science, data science, mathematics, or a preferred major in statistics.

• Over 7 years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or a similar team, with experience in supporting drug development, medical device development, or intervention studies.

• Exceptional SAS programming proficiency and expertise in the creation and execution of statistical programming procedures and processes within a clinical development setting.

• Extensive practical experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations.

• Experience in supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities.

• Ability to work independently is essential.

• Exceptional communication skills (both written and verbal) along with strong leadership abilities.

🏝️ Benefits

• Our commitment to developing our staff is only matched by our dedication to advancing treatment options available to patients.

• We strive to create successful careers with substantial professional growth for our employees, which in turn contributes to Cytel's success.