Director, Scientific Programming

Essential Duties & Responsibilities

• Collaborate with lead project Biostatistician in project strategic planning and provide overall guidance to the programming team in creation, implementation, and maintenance of programming development plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned; ensure that all programming has been carried out per industry and internal standard practice.
• Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines.
• Lead or contribute to the development and implementation of programming resource algorithm.
• Collaborate with managers, responsible and accountable for project resource planning and tracking.
• Collaborate with intelligent solutions team to develop and implement cutting-edge automation and innovation solutions for delivery and project management.
• Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, Medical Monitors, and other functions to address programming related study deliverables.
• Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.
• Provide strategies for programming related matters in submission to regulatory agencies, publications and other communications as needed.
• Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities.
• Provide expert guidance for programming group on complex programming tasks and/or standards.
• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents.
• Oversee the projects for the creation of analysis datasets, production / validation of output, and review of annotated case report forms.
• Lead the statistical programming support of FDA/EMA/CDE regulatory submissions follow CDISC standards.
• Contribute to departmental process and standards initiatives such as tools and CDISC standards.
• Collaborate and support the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.
• Oversee the work in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards.
• Lead the development of TAUG (therapeutic area users guide) following industry and regulatory standards.
• Other duties as assigned.

  Core Competencies, Knowledge And Skill Requirements

  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
  • Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed).
  • Computer programming using SAS.
  • Fundamentals of project planning and management.
  • Drug development process.
  • Excellent verbal and written communication skills.
  • Effective collaboration in a dynamic environment.
  • Significant Contacts: Interacts with project team members at all levels.

  Desired Background And Experience

  • Experience leading teams supporting FDA/EMA/CDE 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.
  • Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.
  • Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.
  • Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).
  • Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making).
  • Experience in development and implementation of statistical programming standards and procedures.
  • Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research.
  • Expert level SAS programmer with experience in delivering complex programming assignments and analysis.
  • Proficient in developing their own code as well as modifying existing code.
  • Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus.
  • Experience with R/Spotfire/Python a plus.

  Requirements

  • Education: Master’s degree or PhD preferred or equivalent related experience.
  • Experience: 10+ years with Bachelor's, 7+ years with Master's and 5+ years with Phd.
  • Requirements: 5+ years of demonstrated leadership experience.