As member of the Project Based Services (PBS) department, and reporting to the Global Head of Statistical Programming or to the local manager (Director statistical programming or Associate director of statistical programming), the main responsibilities of the Senior Statistical Programmer will be to:
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Lead, or contribute to, statistical programming activities on PBS projects (development or QC of deliverables):
- delivering exemplary perfrmance and solving complex technical problems to inspire other programmers,
- ensuring an efficient cllaboration with PBS global teams (Europe, India, and US)
- being accuntable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
- being accuntable for overall client satisfaction with these deliverables,
- maintaining a detailed prject and validation plan,
- efficiently cmmunicating with internal and external clients,
- ensuring budget mnitoring and adherence
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Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
- Clinical study reprting, e.g. ICH E3
- Electrnic records handling, e.g. Chapter 21 of the US Code of Federal Regulation – Part 11
- Electrnic 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 PBS 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.
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 6 years f experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
- Experience as a lead statistical prgrammer on several concurrent projects
- Prficient in SAS
- God knowledge of CDISC ADaM and SDTM.
- God understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
- God knowledge of relevant regulatory and data submission guidelines.
- Prject management skills
- Fluent in English (French and/r German is a plus)
- Ability t 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 t rapidly understand and anticipate the needs of internal and external customers, and respond to their inquiries
- God negotiation and issue resolution skills
- Ability t 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.
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