Principal Statistical Programmer

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

📋 Description

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

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

• Ensure the delivery of high-quality statistical programming outcomes by developing, validating, and maintaining SAS and/or R programs tailored to the needs of clinical development programs.

• Oversee CRO’s statistical programming deliverables for multiple clinical studies to guarantee high quality and adherence to pre-established timelines.

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

• Understand and comply with FDA regulations influencing the reporting of clinical trial data.

• Aid in the creation, maintenance, documentation, and validation of programming tools, outputs, and macros standards.

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

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

• Collaborate with internal and external teams (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 pertinent to statistical programming practices.

⛳️ Requirements

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

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

• Exceptional SAS programming abilities and proficiency in the development and implementation of statistical programming procedures and processes within a clinical development context.

• Extensive hands-on 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 agencies.

• Ability to work independently is essential.

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

• Preferred Qualifications (a plus): Previous experience with pharmacokinetic data and the neuroscience sector, proficiency in additional languages or tools beyond SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, and git).

🏝️ Benefits

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

• We strive to foster successful careers with significant professional growth opportunities for our employees.

• Cytel is a place where talent, experience, and integrity unite to advance the field of clinical development.