Summary:

Manager, Statistical Programming and Data Operations (SPDO) in Biostatistics is responsible for vendor oversight and management to deliver the high-quality tables, listings, and figures (TLFs), as well as CDISC datasets for clinical trials and integrated statistical analysis intended for regulatory submissions, interfacing with cross-regional staffs in establishing and maintaining global data standards and department procedures.

Essential Functions:

Vendor Oversight and Management
• Responsible for developing TLF shells, CDISC deliverables, and TLFs in collaboration with stat/programming vendors.
• Participate in vendor selection/oversight processes: Create and/or review Requests for Proposal (RFP); track the progress of stat/programming activities and the project budget for stat/programming vendor; and manage the timeline of stat/programming deliverables.
• Collaborate with stat/programming vendors to ensure all statistical deliverables from the vendor meet timelines with quality. Oversee all aspects of statistical programming tasks performed by the vendor.
• Manage the stat/programming related TMFs in collaboration with stat/programming vendors and act as a subject matter expert at FDA inspections.

Internal Collaboration
• Interface with in-house staff: Participate on project team meetings; and manage the cost and timeline of stat/programming activities in collaboration with each project manager.
• Review protocols, case report forms, statistical analysis plans, specifications for raw data, clinical study reports, and the other study-related documents.
• Collaborate with biostatistician to provide statistical programming input on project topics and issues.

Statistical Programming
• Responsible for preparation of CDISC data submission package and SAS programming for regulatory documents (e.g. Response to information requests from HA; Integrated summaries; BIMO; and DSUR).
• Provide statistical programming for publications and presentations, ad-hoc and post-hoc analyses of clinical study data.
• Conduct programming QC reviews of vendor deliverables in accordance with internal guidelines and work instructions.
• Support departmental initiatives related to process building/improvement of programming activities.
• Coordinate and liaise with our Japanese colleagues, as needed, regarding global procedures, processes, and standards.

Requirements:

Education
Bachelor's Degree or higher in Computer Science, Statistics, or closely related discipline.

Experience
• Proven experience in statistical programming for clinical trials in the life sciences industry: six or more years with a Master's degree, or eight or more years with a Bachelor's degree.
• Experience in study oversight of statistical analysis for clinical trials in the life science industry
• Demonstrated expertise in CDISC standards and CDISC compliant submission requirements.
• Experience in data integration for ISS/ISE across multiple studies for regulatory submissions (preferred)
• Experience in using SAS-LSAF (i.e. Life Science Analytics Framework), including its repository and programming environment (preferred)

Technical Skills
• Excellent proficiency in SAS (required); Advance skill in R (preferred).
• Highly skilled in Microsoft Office applications (Word, PowerPoint, Excel, Outlook).
• Familiarity with ICH guidelines (especially E9) and other regulatory guidance.
• Solid understanding of development, regulatory and commercial aspects of drug development.

The anticipated salary for this position will be $145,000 to $160,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

#Hybrid #Princeton