Associate Director, Statistical Programming Pbs

• Contribute to the development of a strong team of statistical programmers, by functionally managing and guiding the programmers with respect to statistical programming strategy, deliverables, processes, and professional development.
• Provide leadership in organizing teamwork, prioritizing and balancing concurrent tasks and responsibilities ensuring high quality, respecting timelines and adherence to the budget.
• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…) as well as SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements.
• Lead or support statistical programming activities for assigned projects, which could include Pooling projects (e.g. ISS/ISE) expected to be submitted to regulatory authorities, as needed.
• Contribute to the development of the department by being involved in the recruitment process.
• Contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures, as needed.
• Lead, or contribute to the design of new statistical programming processes/systems or optimization of existing ones that streamline operations to increase statistical programming efficiency, as needed.
• Occasionally, interact with regulatory agencies regarding specifications for electronic submissions, and direct/develop statistical programming electronic submission deliverables.
• Contribute to budget evaluation for proposal writing purpose and be programming representative during bid-defense, as needed.
• Serve as the programming representative during audits.
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
  • Clinical study reporting, e.g. ICH E3
  • Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
  • Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards
• Understand and follow all relevant standard operating procedures (SOPs).
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.

Education: BSc or equivalent with research experience, and/or MS (preferably in Statistics, Computer Science, or Mathematics). Master’s Degree preferred.

Experience: Minimum 12 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with excellent knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines and proven experience in the development of advanced macros. 2 years of experience as a statistical programming team manager or as leading global initiative across an organization. Consistent experience as a lead statistical programmer on several concurrent projects.

Skills:

• Fluent in English and good written / verbal communication skills
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Proficient in SAS programming, R programming skills a plus.
• Ability to organize teamwork and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills.
• Good knowledge of the pharmaceutical industry including understanding of clinical drug development process and data submission guidelines.
• Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements along with the ability to rapidly understand and anticipate the needs of internal and external customers and respond to their inquiries.
• Ability to work effectively in global teams, effectively operates within a matrix organization and with multi-disciplinary groups, excellent team player with strong interpersonal skills contributing to building the team spirit.