Senior Statistical Programmer, SAS, R

This is a fully remote position, open to applicants in Poland, +5 more countries.

📋 Description

• Create SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml files for various studies.

• Design SAS/R programs to produce datasets, complex listings, tables, and graphs.

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

• Supervise CRO statistical programming outputs across multiple 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 guidelines.

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

• Engage in the development of CRFs, edit check specifications, and data validation plans.

• Review and/or produce data transfer specifications for external vendor datasets.

• Collaborate with CROs, software vendors, clinical development partners, and internal departments to achieve project deadlines and objectives.

• Review and/or draft SOPs and work instructions related to statistical programming practices.

• Monitor progress and provide expert technical assistance to team members.

• Conduct reporting and analysis activities for Sponsor clinical trials.

⛳️ Requirements

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

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

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

• Exceptional proficiency in SAS programming and a thorough understanding of clinical development programming procedures and processes.

• Extensive practical experience with CDISC standards, including SDTM, ADaM, and Define.xml.

• Familiarity with medical terminology and methodologies in clinical trials.

• Understanding of FDA/ICH regulations.

• Experience in supporting regulatory submissions and liaising with the FDA and/or global regulatory bodies.

• Capability to work independently.

• Excellent written and verbal communication abilities.

• Strong leadership qualities.

• Preferred: experience with pharmacokinetic data and neuroscience.

• Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, and git.

• Good R experience as outlined in the internal qualifications.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.

• Fully integrated working environment within a pharmaceutical client with Cytel support.