**Permanent / Contract, Remote Principal Statistical Programmer- UK, Germany, Switzerland, Austria, Poland***
Cytel is shaping the future of drug development. As the world's largest independent clinical biostatistics research and development organization, we collaborate with leading pharmaceutical, biotech and medical device companies helping them to improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software.
Due to recent growth on a global scale we are currently hiring Principal Statistical Programmers to join our organisation.
As member of the Biostatistics and Data Management (BDM) department, and reporting to the Global Head of Statistical Programming or to the local manager (Director / Associate Director of statistical programming) you will be working with respected experts and leaders in the fields of biostatistics and statistical programming contributing to the delivery of life changing medicines.
Your main responsibilities will be:
- Providing leadership in promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.
- Leading or contributing 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 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,
- ensuring budget monitoring and adherence,
- ensuring 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
- Providing input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…)
- Understanding, following and ensuring adherence to all BDM SOPs as well as any other relevant SOPs.
- Keeping 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.
Occasionally, responsibilities will also include to:
- Contributing to the development of a strong team of statistical programmers in the US, by functionally managing local programmers with respect to statistical programming strategy, deliverables, processes, and professional development
- Contributing to budget evaluation for proposal writing purpose.
- Leading or contributing 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.
- 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!
Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
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