Cytel is shaping the future of drug development. As the world's largest independent clinical biostatistics research and development organization, we help leading pharmaceutical, biotech and medical device companies improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software. With operations across North America, Europe, and India, we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.
We are experiencing exponential growth on a global scale and hiring a Director Statistical Programmer to join our PBS division. You will exercise your strong communication and leadership skills to support or lead one or more clinical trials, across various therapeutic areas. You will report to the Senior Director, Statistical Programming.
Summary of Job Responsibilities:
As member of the Project Based Services (PBS) division, and reporting to the Global Head, Statistical Programming or Senior Director of Statistical Programming, the main responsibilities of the Director Statistical Programming will be to:
- Contribute to the development of a strong team of statistical programmers, by functionally managing local programmers with respect to statistical programming strategy, deliverables, processes, and professional development
- 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.
- Lead, or contribute to, statistical programming activities on BDM projects (development or QC of deliverables):
- delivering exemplary performance and solving complex technical problems to inspire other programmers,
- ensuring an efficient collaboration with BDM teams in USA, Europe and India,
- being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
- being accountable for overall client satisfaction with these deliverables,
- maintaining a detailed project and validation plan,
- efficiently communicating with internal and external clients,
- and ensuring budget monitoring and adherence
- 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
- Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…)
- Understand, follow and ensure adherence to all BDM SOPs as well as any other relevant SOPs.
- Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
- When needed, 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.
- Lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.
Qualifications and Experience:
- Minimum Education: BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)
- Preferably at least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
- Preferably 2 years of experience as a statistical programming team leader or manager
- Consistent experience as a lead statistical programmer on several concurrent projects
- Proficient in SAS
- Good knowledge of CDISC ADaM and SDTM.
- Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
- Strong knowledge of relevant regulatory and data submission guidelines.
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management.
- Strong project management skills
- Fluent in English (French and/or German is a plus)
- Ability to work effectively in international 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
- Ability to rapidly understand and anticipate the needs of internal and external customers, and respond to their inquiries
- Good negotiation and issue resolution skills
- Ability to organize team work and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills
- Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements
- Strong mentoring skills
- 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.