JOB SUMMARY

The Director, Statistical Programming is responsible for managing and overseeing all aspects of statistical
programming activities and assigned direct reports globally. This includes managing complex or portfolio level
programming study deliverables, participating in the development and maintenance of departmental
standards, developing and maintaining macros. The Director will work to ensure all timelines and deliverable
objectives are met with high quality and to the clients’ satisfaction. They will assist with and lead in the
evaluation and implementation of new statistical programming methods and technology to ensure up-todate
and innovative standards are implemented.
Will be responsible for supporting the department leader with revenue recognition, forecasting, and
reporting. Furthermore, he/she is also responsible for the allocation and forecasting of resources for both
the Full-Service and Functional Service Provider models.

ESSENTIAL DITING & RESPONSIBILITIES

• Responsibilities
  • Contribute to department financial planning and tracking to financial targets
  • Review metrics for department performance; identify and address risks or areas of concern
  • Identify and drive process improvements
  • Onboarding of new employees; including training on statistical programming procedures and
    systems
  • Coordinate the resourcing workload and forecast of the Statistical Programming team globally to
    ensure deliverables and timelines are met and deliverables represent high quality to the clients’
    satisfaction
  • 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
  • Support project budget oversight; including revenue recognition, forecasting, billing, invoicing
    and change orders
  • Identify and manage project risks
  • Participate in biostatistics candidate interviews
  • Maximize productivity of direct reports to meet budget goals
  • Support the facilitation of 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 including but not limited to R, AI, and other industry leading
    methods
  • 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
    • Define.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
  • Create material and present at study kick-off meetings, investigator meetings, client meetings,
    etc.
  • Attend workshops, seminars and conferences, to maintain current professional knowledge of
    data management technologies
• Standard Operating Procedures (SOPs)
  • Strong understanding of departmental and company procedures; ability to guide others on
    procedures
  • Create, revise and/or review department documentation; including, SOPs, templates and work
    instructions
  • Participate in the development and revision of department SOPs
  • Ensure staff are adequately trained on and are following SOPs
• Business Development
  • Attend business development, bid defense and capabilities meetings; Develop and maintain
    presentations
  • Support the business development process; including RFI completion, proposal development,
    and 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

• Education
  • An advanced degree (MS or PhD) in Statistics, Computer Science, or a closely related field or
    equivalent combination of education and experience.
• Experience
  • Minimum of 10 years’ direct SAS programming experience in pharmaceutical development or
    CRO environment
  • Strong SAS programming skills, knowledge of clinical trial conduct and industry standards are
    required
  • Working knowledge of CDISC (SDTM and ADaM) standards, including specification writing and programming of datasets
  • Working knowledge of TLF shell creation and programming of TLFs
  • The ideal candidate will have 4 years of management/leadership experience, but is not required
  • Excellent oral and written communication skills, organizational skills, and attention to detail are
    required
  • Understanding of regulatory guidance documents (e.g. ICH, 21 CFR Part 11, GCP, etc.)
  • Ability to balance multiple projects simultaneously and to take on additional projects when
    necessary
• Certification
  • SAS certification (Base and Advanced) is preferred

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.).