Principal Statistical Programming - Remote - FSP at Cytel

Summary of Job Responsibilities:

As member of the Functional Service Provider (FSP) group, and reporting to the Director / Associate Director of statistical programming, the main responsibilities of the Principal Statistical Programmer will be to:

• Provide leadership in promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.
• Lead, or contribute to, statistical programming activities on FSP 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,
• 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 CRS WIs/SOP as well as any other Client relevant WI/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.

Occasionally, responsibilities will also include 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
• 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)

Minimum Work Requirements:

• Preferably at least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
• Consistent experience as a lead statistical programmer on several concurrent projects
• Proficient in SAS
• Strong 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..
• Strong project management skills