Senior Statistical Programmer

hace 1 semana

Madrid, Madrid, España Cytel - Emea A tiempo completo
Senior Statistical Programmer

Cytel is a leading clinical biostatistics research and development organization, helping pharmaceutical, biotech, and medical device companies improve clinical success rates. We are seeking a Senior Statistical Programmer to join our FSP division, supporting or leading clinical trials across various therapeutic areas.

Key Responsibilities:
  • Provide technical expertise for statistical programming in all phases of programming support, developing automated reports and preparation of submission data standard packages.
  • Support statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
  • Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures.
  • Design and maintain statistical datasets that support multiple stakeholder groups.
  • Serve as a key collaborator with statistics and other project stakeholders to ensure project plans are executed efficiently with timely and high-quality deliverables.
  • Be able to serve as a statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol if/when called upon.
  • Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
  • Maintain and manage a project plan, including resource forecasting.
  • Coordinate the activities of the supplier's programming team and interact with client statistical programmers.
  • Utilize strong project management skills and ability to engage key stakeholders, leadership at a protocol level, determining approach and ensuring consistency, and directing development of others when opportunities arise.
  • Design and develop complex programming algorithms.
  • Comprehend analysis plans, which may describe methodology to be programmed, and understand statistical terminology and concepts.
  • Utilize expertise in CDISC and ADaM standards.
  • Statistical programming for early and late-stage clinical trials, which can include both planned and ad-hoc needs.

Cytel is shaping the future of drug development, and we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.

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