Statistical Programmer II

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

📋 Description

• Collaborates effectively with Clinical Development personnel to achieve project deadlines and deliverables related to statistical data analysis and reporting.

• Evaluates the quality and consistency of analysis data while conducting cross-study analyses.

• Utilizes internal macros or develops SAS® macros to streamline study deliverables.

• Aids in the submission of electronic data (e.g., SAS® datasets) to regulatory bodies.

• Possesses adequate knowledge to adhere to an analysis plan and provide programming assistance for study deliverables.

• Participates in the review of GSI Policies, SOPs, and other regulated documents.

• Offers input and engages in Programming and Clinical Data Science meetings.

• Contributes to the ongoing enhancement of the Programming Environment.

• Exhibits proficiency in SAS programming.

• Produces statistical analysis datasets and outputs (e.g., tables, figures, and listings) for study reports and integrated summaries.

• Understands clinical trial study design and the requirements for electronic data submission.

• Assists with study and system audits and addresses audit inquiries and findings.

• Works in collaboration with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies and aids in defining the dataset.

⛳️ Requirements

• Master's degree with 2 years of relevant experience OR Bachelor's degree with 4 years of relevant experience.

• Degree in Biostatistics/Computer Science or a related field (preferred).

• Over 5 years of experience in the pharmaceutical/CRO industry (preferred).

• Previous experience in oncology, hematology, or cell therapy is strongly preferred.

• Strong preference for knowledge related to long-term follow-up trials.

• Practical experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.) (preferred).

• Comprehensive understanding of clinical programming and/or statistical programming processes and standards.

• Extensive knowledge of regulatory requirements pertinent to statistical programming (e.g., GCP, ICH).

• Significant experience in statistical programming using SAS and R software, including the development and application of SAS Macros and R Packages.

• Experience in developing CDISC standardized ADaM datasets and specifications.

• Advanced knowledge of SDTM domains.

• Demonstrated experience in leading programming initiatives.

• Exceptional interpersonal, communication, problem-solving, and analytical abilities.

• Willingness to manage multiple projects and ad-hoc assignments.

🏝️ Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives (eligibility may vary based on role).

• Paid time off.