The Senior Manager, Statistical Programming is responsible for managing all aspects of statistical programming activities and assigned direct reports. This includes managing complex or portfolio-level programming study deliverables, participating in the development and maintenance of departmental standards, training and mentoring staff, as well as developing and maintaining macros.

Responsibilities:

• Onboarding of new employees; including training on statistical programming procedures and systems
• Coordinate the workload of the Statistical Programming team to ensure deliverables and timelines are met
• Mentor, monitor and supervise direct reports (including monitoring time reporting and training requirements)
• Responsible for the hiring, promotion, transfer and release of staff
• Conduct performance reviews and assist with goal setting of direct reports
• Provide input on resource planning and assignments
• Project budget oversight; including revenue recognition, forecasting, billing, invoicing and change orders
• Identify and manage project risks
• Participate in biostatistics candidate interviews
• Implement and maintain performance metrics
• Maximize productivity of direct reports to meet budget goals
• Contribute to department financial planning and tracking to financial targets
• Facilitate department meetings
• Ensure all programming deliverables follow departmental standards and programming specifications and are of the highest quality
• Contribute to the development and implementation of programming standards and templates
• Drive department initiatives
• Implement and support CDISC and other regulatory standards
• Develop training materials and deliver training
• Identify improvements to current processes, drive development of updated/new processes.
• Design, develop, document, validate and maintain macros and utilities to improve quality and efficiency of processes
• Serve as Statistical Programmer for complex studies or large client portfolios. Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:
  • Analysis datasets (SDTM, ADaM, other derived datasets)
  • Tables, listings and figures
  • xml/Reviewer’s Guide
  • Integrated summaries
• Work effectively with biometrics colleagues and other cross-functional team members to ensure accurate and high-quality statistical outputs

• Standard Operating Procedures (SOPs)
  • Strong understanding of departmental and company procedures; ability to guide others on procedures
  • Participate in the development and revision of department SOPs
  • Ensure staff are adequately trained on and are following SOPs
• Business Development
  • Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities
  • Assist in the preparation and review of monthly financial reporting
  • Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
  • Perform other duties as requested by management

Qualifications:

• An advanced degree (MS or PhD) in Statistics, Computer Science, or a closely related field; work experience may be substituted for degree
• Minimum of 8 years direct SAS programming experience in pharmaceutical development or CRO environment
• Strong SAS programming skills, knowledge clinical trial conduct and industry standards are required
• The ideal candidate will have 4+ years of management/leadership experience preferred
• Excellent oral and written communication skills, organizational skills, and attention to detail are required