Lead the biometrics team including statisticians, data managers, and statistical programmers at a program level, providing strategic input for clinical development.
Author and develop Statistical Analysis Plans (SAPs), contribute to trial designs, protocol development, and sample size calculations, and oversee vendor deliverables.
Interact with global health authorities, contribute to regulatory submissions, and coordinate statistical analyses for safety updates and ad hoc requests.
Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Mentors peers on statistical methodology and manages activities of statisticians across projects.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, we have a supportive culture and below industry average turnover rates.
Partner with medical and cross-functional teams to provide statistical leadership for real-world evidence and publication strategies.
Perform advanced statistical analyses including meta-analyses, causal inference, and external control studies.
Write statistical analysis plans, review medical literature, and ensure quality of statistical programming.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. The company offers the security and career opportunities of a global organization while allowing direct work with a single sponsor.
Maintains responsibility for all assigned biostatistics duties within clinical studies, including acting as study lead for multiple or complex studies.
Reviews and develops clinical program designs, protocols, and statistical analysis plans, ensuring high-quality and valid content.
Provides mentoring to junior statisticians and represents the biostatistics function in internal and external meetings and audits.
Ergomed Group is a rapidly expanding full-service mid-sized CRO specialising in Oncology and Rare Disease. Since 1997, the company has grown organically with operations in Europe, North America and Asia, fostering a true international culture that values employee experience, well-being, and work-life balance.
Lead programming activities for oncology clinical trials, developing and validating SDTM and ADaM datasets following CDISC standards.
Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and regulatory submissions.
Collaborate with Biostatistics, Data Management, and Regulatory Affairs to ensure compliance with FDA, EMA, and PMDA requirements.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience, they employ more than 4,000 professionals across 20+ countries, fostering a culture of diversity and continuous training.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Lead and support all programming activities for clinical studies, including developing Tables, Figures, and Listings (TFLs) using SAS for Clinical Study Reports and regulatory submissions.
Work independently to implement programming strategies, ensure compliance with standards, and contribute to best practices for quality and efficiency.
Communicate and escalate risks, support team activities, and coordinate with biostatisticians to customize outputs for target audiences.
ClinChoice is a global full-service clinical research organization specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience and more than 4,000 professionals across 20+ countries, the company fosters a supportive culture focused on quality, professional development, and low employee turnover.
Provides statistical consulting, study design, and data analysis for clinical trials.
Communicates complex statistical concepts to non-statistical stakeholders and clients.
Supports business development, thought leadership, and scientific publications.
Alimentiv is a clinical research organization that provides biostatistical and clinical services to pharmaceutical and biotech clients. They have a Statistical Center of Excellence and offer a remote-based role with a focus on innovation and regulatory compliance.
Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.
Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.