Senior/Principal Statistical Programmer, SAS, R

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

📋 Description

• Independently manage clinical development programs across various therapeutic areas.

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

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

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

• Supervise CRO statistical programming deliverables across multiple clinical trials.

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

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

• 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 or compose data transfer specifications for external vendor data.

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

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

• Provide expert technical assistance and track progress while reporting to the Director of Biostatistics and Programming.

⛳️ 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 on a Biotech/Pharma Clinical Development Biometrics Team or a comparable team.

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

• Exceptional skills in SAS programming and proficiency 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 liaising with the FDA and/or global regulatory authorities.

• Capability to work independently.

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

• Preferred: previous experience with pharmacokinetic data and neuroscience.

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

🏝️ Benefits

• Regular training, development, and support.

• Significant opportunities for professional growth.