Director, Statistical Programming US

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. We are experiencing exponential growth on a global scale and hiring a Director Statistical Programmer to join our PBS division. You will report to the Global Head of Statistical Programming.

JOB SUMMARY:

Provide leadership to the team and contributes to strategy and vision within the Services department. Utilizes experience to resolve most issues and discussions finding efficient solutions. Responsible for defining and streamlining required processes and setting up and managing client expectations in terms of performance and quality. Understands the organization's growth, goals and objectives, especially in new lines of business such as end-to-end services delivery and participates in bringing them to fruition.

JOB RESPONSIBILITIES:

• Engage with Executive leadership team and participate in development of global strategy and execution of its mission.
• Contribute to the development of a strong statistical programming team of leaders/managers, by functionally supervising and mentoring with respect to statistical programming strategy, deliverables, processes, and professional development.
• Direct line management responsibility includes recruiting, hiring, training, development, setting goals/objectives, performance assessment, in collaboration with the Global Head of Statistical programming.
• Provide leadership in promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.
• Provide leadership in balancing conflicting priorities.
• As a line manager, be accountable for the quality, traceability, reproducibility, budget adherence and timeliness of statistical programming deliverables for the group/team of statistical programmers.
• Contribute to the development of the department by being involved in the recruitment process.
• Represent statistical programming department during audit.
• When needed, interact with regulatory agencies regarding specifications for electronic submissions, and direct statistical programming electronic submission deliverables.
• Contribute to budget evaluation for proposal writing purpose and be programming representative during bid-defense, 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.
• 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

QUALIFICATIONS:

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 processes/tools. 6 years of experience as a statistical programming team manager or as leading global initiative across an organization that streamline operations to increase efficiency. Excellent understanding of drug development, including submissions experience (pooling programming activity and submission documents) and knowledge of interfaces and interdependencies with other functions.

Skills: Fluent in English and good written / verbal communication skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent understanding of clinical drug development process, including submissions experience (pooling programming activity and submission documents) and knowledge of interfaces and interdependencies with other functions. Advanced 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. Self-directed, technically strong, and a recognized leader maintaining a strategic prospective regarding statistical programming processes, management of statistical programmers and customer management. Good negotiation and issue resolution skills. 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.

Why Cytel?

Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry. In addition to a competitive compensation, we offer an excellent benefit's package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us! Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.