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

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Senior Manager, Statistical Programming

Job Description

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