O pozici
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for an Senior Biostatistician Consultant to join one of our clients in V&I (Vaccines & Infectious disease ) department
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Co budeš dělat
- Lead statistical input for clinical trial design, including protocol development and sample size calculations
- Develop and review Statistical Analysis Plans (SAPs)
- Provide oversight of statistical analyses for clinical studies (Phase I–IV)
- Collaborate with cross-functional teams including Clinical, Data Management, and Programming
- Interpret study results and contribute to clinical study reports (CSRs)
- Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries
- Guide and review work of statistical programmers (SDTM/ADaM, TLFs)
- Ensure compliance with CDISC standards and regulatory guidelines
- Participate in safety and efficacy analyses, including interim analyses
- Provide strategic input for ISS/ISE and integrated analyses
Koho hledáme
- Master’s or PhD in Statistics, Biostatistics, or related field
- 5+ years of experience in clinical trials within pharma/CRO
- Strong experience in Vaccines & Infectious Diseases
- In-depth knowledge of clinical trial methodology and statistical principles
- Experience with regulatory submissions (FDA/EMA)
- Proficiency in SAS ; knowledge of R is a plus
- Strong understanding of CDISC (SDTM/ADaM) standards
- Excellent communication and stakeholder management skills
Benefity
- working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring
- global full-service CRO with a strong focus on quality, professional development, and supportive culture
- equal opportunity employer
- diversity and inclusivity
- below industry average turnover rates
