Cytel
Location
India | India
Job description
Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. 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.
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): o delivering exemplary performance and solving complex technical problems to inspire other programmers, o ensuring an efficient collaboration with BDM teams in Europe and India, o being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables, o being accountable for overall client satisfaction with these deliverables, o maintaining a detailed project and validation plan, o efficiently communicating with internal and external clients, o and ensuring budget monitoring and adherence . Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance: o Clinical study reporting, e.g. ICH E3 o Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11 o 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.
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