Principal Statistical Programmer

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

📋 Description

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

• Develop SAS programs to generate datasets, intricate listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.

• Deliver high-quality statistical programming results by developing, validating, and maintaining SAS and/or R programs tailored to the requirements of clinical development programs.

• Participate in overseeing the statistical programming deliverables from CROs for multiple clinical studies to ensure quality and compliance with pre-established timelines.

• Assist in the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.

• Comprehend and adhere to FDA regulations that impact the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions.

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

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

• Provide review and/or create data transfer specifications for external vendor data.

• Collaborate with internal and external stakeholders (e.g., CROs, software vendors, clinical development partners, etc.) to ensure project timelines and objectives are met.

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

⛳️ 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 in a Biotech/Pharma Clinical Development Biometrics Team or a similar environment, with a focus on supporting drug development, medical device development, or intervention studies.

• Exceptional SAS programming capabilities and expertise in developing and implementing statistical programming procedures and processes within a clinical development context.

• 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.

• Excellent communication skills (both written and verbal) coupled with strong leadership abilities.

• Prior experience with pharmacokinetic data and in the neuroscience field is a plus.

• Proficiency in programming languages or tools beyond SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, and git) is also an advantage.

🏝️ Benefits

• At Cytel, we prioritize our employees' success and facilitate this through ongoing training, development, and support.