Manager, Statistical Programming

906

Workplace Type:
Remote

JOB SUMMARY

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

ESSENTIAL DUTIES AND RESPONSIBILITIES

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
• 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
• 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 2 years of management/leadership experience, but is not required
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

ROLE COMPETENCIES

• Thorough understanding of the skills and knowledge relevant to the function. Successful experience in a variety of complex assignments under normal supervision.
• Tailors communication (e.g. content, style, and medium) to diverse audiences. Communicates equally effectively at varied organizational levels. High level of written, presentation, and verbal communication skills.
• Searches for ways, ideas and mechanisms to add value to the customer. Develops services and options to support ongoing customer relationships. Prioritizes customer issues and addresses them accordingly.
• Develops new approaches to improve or replace existing procedures or systems. Tries to break new ground and be creative when generating solutions. Looks beyond the obvious and immediate information when generating solutions.
• Organizes and executes multiple projects/ tasks. Organizes workflow processes to achieve efficiency. Adapts to situational variables and unexpected changes in circumstances.
• Contributes to change initiatives with enthusiasm and is a supporter of ideas and innovation. Serves as a resource for problems affecting moderate scale projects or systems. Serves as a resource to others.
• Ensures standardization is applied to all processes- creating, developing, improving, and complying with standards. Proactively identifies process improvement opportunities while taking industry trends and best practices into consideration.
• Recognize, exemplify and adhere to Advanced Clinical's values which center around the REAL values and inspire peers and colleagues cross-functionally to live and work by these values.

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.