Manager, Statistical Programming

Responsibilities

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Serves as project leader.
• Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries.
• Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Actively share experience and discuss possible process enhancements at programming meetings.
• Recommends potential trainings.
• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
• Able to lead and manage multiple concurrent projects.
• Excellent verbal and written communication skills and interpersonal skills.
• Thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions.
• Ability to resolve study related issues and conflicts within a therapeutic project.
• Can create buy-in and support and has the ability to negotiate timelines.
• Interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
• Participates in SMT (Study Management Team) meeting as a representative of Programming group.

Qualifications

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience.
• Preferred: Degree in Biostatistics/Computer Science or equivalent 6+ years of pharmaceutical/CRO experience.
• Prior experience in oncology, hematology, and cell therapy is strongly preferred.
• Knowledge of long term follow up trial knowledge strongly preferred.
• Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.).
• In-depth understanding of clinical programming and/or statistical programming processes and standards.
• In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros.
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven experience in leading programming activities.
• Excellent interpersonal, communication, problem solving, and analytical skills.

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.