Senior/Principal Statistical Programmer, FSP, SAS, R

This is a fully remote position, open to applicants in Poland, +4 more countries.

📋 Description

• Create specifications for SDTM and ADaM, datasets, review guides, and Define.xml files for various studies.

• Design SAS programs to produce datasets, intricate listings, tables, descriptive and inferential statistics, and advanced graphs.

• Develop, validate, and sustain SAS and/or R programs for clinical development initiatives.

• Manage CRO statistical programming outputs across numerous clinical trials.

• Assist with clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses.

• Adhere to FDA regulations, good clinical practices, and electronic submission standards.

• Develop, maintain, document, and validate programming tools, outputs, macros, and standards.

• Engage in CRF development, edit check specifications, and data validation strategies.

• Review or create data transfer specifications for external vendor data.

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

• Review or draft SOPs and work instructions pertaining to statistical programming.

⛳️ Requirements

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

• Over 7 years of experience as a Statistical Programmer within a Biotech/Pharma Clinical Development Biometrics Team or a comparable team.

• Experience in supporting drug development, medical device development, or intervention studies.

• Exceptional SAS programming skills and proficiency in developing and executing statistical programming procedures and processes in a clinical development context.

• Practical experience in R programming.

• Extensive hands-on experience with CDISC standards, including SDTM, ADaM, and Define.xml.

• Familiarity with medical terminology, clinical trial methodologies, and FDA/ICH regulations.

• Experience in supporting regulatory submissions and engaging with the FDA and/or global regulatory agencies.

• Capacity to work independently.

• Excellent written and verbal communication skills, along with strong leadership abilities.

• Preferred: experience with pharmacokinetic data and neuroscience.

• Preferred: proficiency in additional tools or languages such as Python, Java, Shiny, Markdown, Unix/Linux, and git.

🏝️ Benefits

• Ongoing training, development, and support.

• Substantial opportunities for professional growth.

• Cytel support while fully integrated within a pharmaceutical client.