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Clinical Outcomes Solutions
Clinical Outcomes Solutions
51 – 200 Angajați
Sponsor pentru viza H1BAsistență medicalăBiotehnologieConsultanță
Clinical Outcomes Solutions este o companie globală de consultanță axată pe cercetarea privind evaluarea rezultatelor clinice (COA) pentru organizații farmaceutice și de biotehnologie. Echipa sa dezvoltă strategii de cercetare și soluții practice pentru colectarea unor date fiabile despre experiențele pacienților, ajutând clienții să abordeze complexitățile științifice și de reglementare ale activității privind rezultatele clinice. Prin integrarea perspectivei pacientului în proiectarea cercetării și generarea de dovezi, compania sprijină luarea unor decizii informate privind îngrijirea și obținerea unor rezultate mai bune pentru pacienți.
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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.

GBRegatul UnitRemoteNormă întreagăLiderLimbă Obligatorie: englezăCercetare clinică

Descriere

  • 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

Cerințe

  • 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

Beneficii

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

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