Clinical Outcomes Solutions
Clinical Outcomes Solutions
Clinical Outcomes Solutions yra pasaulinė konsultacijų įmonė, daugiausia dėmesio skirianti farmacijos ir biotechnologijų organizacijų klinikinių rezultatų vertinimo (COA) tyrimams. Jos komanda kuria tyrimų strategijas ir praktinius sprendimus, skirtus patikimiems duomenims apie pacientų patirtis rinkti, taip pat padeda klientams spręsti su klinikinių rezultatų darbu susijusius mokslinius ir reguliavimo sudėtingumus. Į tyrimų planavimą ir įrodymų rengimą įtraukdama pacientų balsą, įmonė padeda priimti informacija pagrįstus priežiūros sprendimus ir siekti geresnių pacientų rezultatų.

Principal Biostatistician, FSP – UK Remote

Provide biostatistical support across Phase I–IV clinical trials and regulatory submissions for Cytel’s pharmaceutical clients. Develop SAPs, analyze clinical data, and contribute to integrated clinical study reports.

Aprašymas

  • Support Phase I–IV clinical studies
  • Conduct ad hoc and exploratory analyses for submissions and Health Authority questions
  • Provide statistical guidance throughout clinical studies
  • Contribute to protocol development, study design discussions, and sample size calculations
  • Review CRFs and data review guidelines
  • Create statistical analysis plans, including analysis dataset and TLG specifications
  • Execute statistical analyses and interpret the findings
  • Prepare clinical study reports, including integrated submission summaries
  • Explain statistical methods and the implications of key decisions
  • Work fully embedded with a global pharmaceutical client while receiving support from Cytel
  • Partner with clinical, regulatory, programming, internal, and external teams

Reikalavimai

  • Master’s degree in statistics or a related field
  • At least 3 years of clinical-trial support experience in the pharmaceutical or biotechnology industry
  • CRO experience is strongly preferred
  • Experience with sample size calculations, protocol concept and protocol development, SAPs, and clinical study reports with integrated submission summaries
  • Strong SAS programming skills for quality control of critical outputs and efficacy and safety tables, with the ability to work closely with programmers
  • Strong understanding and practical application of CDISC requirements for regulatory submissions
  • Proficiency in generating ADaM specifications and performing dataset quality control
  • Ability to build effective external and internal relationships and motivate regional or global teams
  • Clear communication skills, including the ability to explain methodologies and decision implications in plain language
  • Knowledge of R programming is advantageous
  • Regulatory work experience is an advantage

Privalumai

  • Ongoing training, development, and support
  • Strong opportunities for professional growth
  • Professional development opportunities

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