Principal Biostatistician

We are looking for this role to support biostatistical activities in the analysis of clinical trials, acting as the Statistical Lead and providing statistical guidance and advice on complex statistical methodology applicable to clinical trials.

Key Responsibilities: 

• Manage and oversee customer relationships on a project level.
• Act as the Lead biostatistician and primary biostatistician contact with the sponsor at the project level. Has overall accountability of quality, appropriateness and correctness of biostatistician deliverables.
• Responsible for biostatistics project management (timelines, scope, budget, resourcing) on a project or program level.
• Write Statistical Analysis Plans (SAPs) for clinical trials. • Development of SAS programs for study TLFs, based on the study SAP and shells. • Provide training/mentorship to statisticians.
• Generate randomization schemes.
• Represent clients at regulatory meetings.
• Provide guidance on study design and statistical methodology during protocol development.
• Review statistical output produced by the statistical programming team.
• Review statistical documentation produced by other statisticians.
• Review the Clinical Study Report (CSR) for appropriateness of statistical methodology described, results reported and conclusions stated.
• Follow the appropriate Standard Operating Procedures (SOPs) for all biostatistics-related activities.
• Ensure that all activities comply with Good Clinical Practices (GCP) standards.

Qualifications:

• Master’s degree in statistics or equivalent experience and education.
• Biostatistician experience required.

Skills:

• Proficient in English. (B2)
• Excellent communication, problem-solving, and collaboration skills.
• Proficient in Microsoft Office products.
• Basic programming knowledge (example SAS, SPSS, or other programming language)