
1001 - 5000 employees
Founded 1998
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą Logistics
ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.
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1001 - 5000 employees
Founded 1998
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą Logistics
ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.
âą Provide statistical leadership across clinical development programs from early-phase studies through late-phase clinical trials âą Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies âą Develop and review clinical study protocols, statistical analysis plans, and other statistical documentation âą Oversee statistical analyses and interpretation of clinical trial data for scientific rigor and regulatory compliance âą Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA âą Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams âą Review statistical outputs, including tables, listings, and figures, for accuracy and consistency with analysis plans âą Apply appropriate statistical methodologies to complex clinical trial design and analysis challenges âą Contribute to clinical study reports, integrated summaries of safety and efficacy, and other regulatory documents âą Identify statistical risks and recommend solutions throughout clinical development âą Provide technical guidance and mentorship to statisticians and other team members
âą PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered âą Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry âą Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies âą Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports âą Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses âą Experience supporting clinical development programs in oncology, rare diseases, and/or neuroscience âą Experience supporting regulatory submissions and health authority interactions âą Experience with complex clinical trial designs and advanced statistical methodologies âą Proficiency in statistical programming tools such as SAS and/or R âą Strong analytical, problem-solving, communication, and stakeholder-management skills âą Ability to work independently and collaborate effectively with global cross-functional teams
âą Professional growth opportunities âą Continuous training and development âą Close management and training to maintain highly qualified personnel âą Equal opportunity and diversity and inclusivity culture
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