Position Summary

The Director of Statistical Programming is responsible for the organization and strategic leadership of a statistical programming unit / therapeutic area that supports multiple drug development programs. The role involves managing a team that develops and validates statistical programs, generates analysis datasets, produces tables, figures, and listings, prepares documentation for electronic submissions, and explores new methodologies to improve the efficiency and productivity of statistical programming.

Essential Duties & Responsibilities

• Collaborate with Product or Project Leads of Statistical Programming in resource planning, allocation, and assignment of programmers to ensure projects are appropriately staffed.

• Lead or contribute to the development or adoption of departmental processes and initiatives focused on operational excellence, resource optimization, standardization, automation, innovation, and CDISC standards implementation.

• Oversee the work of internal and contract programmers, providing guidance, coaching, and career development for all team members.

• Lead or contribute to the selection and management of CROs (including strategic outsourcing providers) for statistical programming activities.

• Supervise staff supporting clinical trials, ad-hoc analysis requests, data validation, etc, and ensure compliance with relevant internal or external standards, procedures, and guidelines.

• Provide managerial support to one or more employees, with overall responsibility of leading, training, and coaching for effective performance.

• Represent statistical programming in cross-functional teams and contribute to process improvement initiatives.

• Lead department culture building and employee engagement efforts.

• Perform other duties as assigned.

Core Technical Competencies, Knowledge, and Skill Requirements

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

• Knowledge of CDISC and other industry/regulatory standards

• Computer programming using SAS or R

• Understanding of project planning and management fundamentals

• Familiarity with the drug development process

Key Leadership Competencies and Skills

• Excellent verbal and written communication skills.

• Ability to effectively collaborate in a dynamic environment.

• Management and leadership skills to set and communicate objectives and goals, prioritize tasks, delegate responsibilities, motivate, and develop team members.

• Strategic planning, critical thinking, and problem-solving capabilities.

Significant Contacts

• Interacts with employees at all levels

DESIRED BACKGROUND AND EXPERIENCE (Include License or Certifications)

• Proven experience leading teams in support of global and regional filings.

• Expert-level knowledge and extensive hands-on experience of CDISC standards such as CDASH, SDTM, and ADaM.

• Experience leading or working with centralized teams for Statistical Programming.

• Adaptable to changing priorities, highly detail-oriented, able to work effectively under pressure with the initiative to tackle unfamiliar tasks.

• Strong ability to establish and communicate a clear plan for the team, ensuring appropriate focus and direction.

• Demonstrated accountability and ownership in both individual and team performance.

• Proven ability to assess the business impact of decisions and remain committed to agreed-upon actions, while being flexible to shifting priorities (judgment and decision- making).

• Experience in the development and implementation of statistical programming standards and procedures.

• Comprehensive understanding of the drug development process (preclinical, early, late-stage, and/or observational studies) in related industries or academic research, with specific experience in oncology trials.

• Expert-level statistical programmer with a track record of delivering complex programming assignments and analyses. Proficient in developing new code as well as modifying existing code.

• Excellent proficiency in Base SAS, SAS/STAT, SAS Macro language, and SAS SQL; experience with SAS/GRAPH is an asset. Familiarity with R/Spotfire/Python is also a plus.

REQUIREMENTS

Education (Indicate if there’s a preferred degree or specified field of study)

• Master’s degree or PhD preferred or equivalent related experience.

Experience

• 11+ years of directly related experience in biometrics (along with a M.S.). 10+ years with a Bachelor’s, and 8+ with a PhD.

• 5+ years of demonstrated leadership experience.

Licenses or Certifications:

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT (AS APPROPRIATE FOR THE POSITION)

• Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)

• Ability to work on a computer for extended periods of time.

• Regularly required to sit for long periods of time, and occasionally stand and walk.

• Regularly required to use hands to operate computer and other office equipment.

• Close vision required for computer usage.

• Occasionally required to stoop, kneel, climb, and lift up to 20 pounds.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.