Senior Statistical Programmer Analyst – Contractor

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

📋 Description

• Assist in the preparation of study data packages for submission in compliance with CDISC standards and FDA guidelines.

• Strategize, implement, and ensure the integrity of statistical analyses.

• Provide support for statistical programming frameworks.

• Collaborate with both internal and external biostatisticians, clinical data managers, and other team members.

• Manage priorities and communicate effectively with stakeholders across Biometrics, research, translational science, clinical science, clinical operations, and regulatory departments.

• Create specifications and develop programs for internal data evaluations, publications, exploratory and post-hoc analyses, as well as regulatory reviews.

• Generate and prioritize analytical deliverables at the study level or integrated level for safety signal detection and other business requirements.

• Collaborate with data management teams to assess case report forms, database specifications, and data transfer specifications.

• Ensure timely and high-quality delivery of analysis results generated by CROs.

• Create and evaluate SDTM/ADaM mapping specifications.

• Produce or validate SDTM domains, ADaM datasets, reviewer’s guides, and define.xml files.

• Create or validate TFLs that support clinical study analyses, regulatory submissions, and publications, including CSR, DSUR, and IB.

⛳️ Requirements

• Bachelor’s or Master’s degree in a data science discipline, such as statistics, mathematics, epidemiology, computer science, bioinformatics, or a related field with equivalent experience.

• At least 8+ years of programming experience with increasing levels of responsibility in a biotechnology or pharmaceutical clinical trial setting.

• Proven experience in software development and testing, including tools such as SAS Macros, R functions/packages, and Unix scripts.

• Proficiency in developing applications with technical stacks including SAS, R, and/or Python.

• Comprehensive understanding of CDISC industry standards, particularly SDTM, controlled terminology, and/or ADaM.

• Demonstrated capability to convert complex problems into clear and concise programming code/tools.

• Fundamental project management skills and experience.

• Strong grasp of programming practices, relevant health authority guidelines such as ICH-GCP and 21 CFR Part 11, and pertinent clinical R&D concepts.

• Excellent written and verbal communication skills.

• Ability to handle conflicting demands and priorities while negotiating effectively.

🏝️ Benefits

• Commitment to equal employment opportunity and non-discrimination.

• Flexibility of remote work arrangements.