The Standard of Excellence
Principal Biostatistician
Location
United States
Posted
11 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Principal Biostatistician
ClinChoice
Role Description We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Key Responsibilities: - Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas. - Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables. - Author and review key statistical documents, including: - Statistical Analysis Plans (SAPs) - Analysis Database Specifications (ADS) - Statistical sections of clinical study reports - Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance. - Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory. - Provide guidance and oversight to statistical programmers as needed. - Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders. - Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs. Qualifications - MS or PhD in Statistics, Biostatistics, or a related field. - Strong experience in Immunology or any TA clinical studies. - Hands-on experience writing: - Statistical Analysis Plans (SAPs) - Analysis Database Specifications - Reviewing and interpreting analysis results - SAS programming skills required (hands-on or strong working knowledge). - Excellent written and verbal communication skills. - Experience working in a CRO and/or pharmaceutical/biotech environment. Requirements - Experience leading Phase II–III clinical trials. - Prior interaction with regulatory agencies. - Experience mentoring junior statisticians or programmers. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
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