Executive / senior industry position
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Date: Aug 24, 2020
Company: Cytel Inc
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.
We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I –IV clinical studies across a variety of therapeutic areas. If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!
As member of the Project Based Services (PBS) department, the primary responsibilities of the Senior Statistical Programmer will be to:
- Delivering exemplary performance and solving complex technical problems to inspire other programmers,
- Ensuring an efficient collaboration with BDM global teams (Europe, India, and US)
- 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
- 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 SOP 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
Occasionally, responsibilities will also include to:
- 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.
- Bachelor degree is required, however Master's degree preferred in Statistics, Computer Science, or Mathematics
- 6 or more years of experience in biostatistics or statistical programming activities in clinical development for Pharmaceutical/Biotechnology industry
- Experience as a lead statistical programmer on several concurrent projects
- Proficient in SAS
- Good understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
- Good knowledge of relevant regulatory and data submission guidelines.
- 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 educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements
- Mentoring skills
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.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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Executive / senior industry position