Clinical Outcomes Solutions
Clinical Outcomes Solutions
Clinical Outcomes Solutions ir globāla konsultāciju sabiedrība, kas koncentrējas uz klīnisko iznākumu novērtēšanas (COA) pētījumiem farmācijas un biotehnoloģiju organizācijām. Tās komanda izstrādā pētījumu stratēģijas un praktiskus risinājumus uzticamu datu iegūšanai par pacientu pieredzi, palīdzot klientiem risināt ar klīnisko iznākumu izpēti saistītos zinātniskos un regulatīvos sarežģījumus. Iekļaujot pacientu viedokli pētījumu izstrādē un pierādījumu veidošanā, uzņēmums atbalsta informētu lēmumu pieņemšanu par aprūpi un labākus pacientu iznākumus.

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.

Apraksts

  • 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

Prasības

  • 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

Priekšrocības

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

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