Sr. Biostatistician

(Must be flexible with US hours)

We are seeking a talented and experienced Senior Biostatistician in solid tumor oncology and submissions to join our team. The successful candidate will lead statistical analysis efforts and provide strategic guidance on study design and data interpretation. The Senior Biostatistician will collaborate closely with cross-functional teams of researchers, clinicians, and analysts to drive evidence-based decision-making and support the development of innovative healthcare solutions.

Responsibilities:

• Lead the design and implementation of statistical analysis plans for clinical trials and research studies.
• Provide statistical expertise and guidance on study design, sample size calculation, and statistical methodologies.
• Perform complex statistical analyses using advanced techniques, such as mixed-effects models, longitudinal data analysis, and survival analysis.
• Develop and validate statistical models to predict outcomes and inform treatment decisions.
• Generate statistical reports, tables, and graphs to summarize study findings and communicate results effectively to stakeholders.
• Collaborate with research teams to ensure data quality and integrity throughout the study lifecycle, from protocol development to final analysis.
• Review and critique study protocols, statistical analysis plans, and study reports to ensure adherence to regulatory requirements and scientific standards.
• Mentor and provide support to junior biostatisticians, including reviewing their work and providing feedback on statistical analyses and methodologies.
• Stay current with advancements in biostatistics, regulatory guidelines, and industry trends, and incorporate best practices into study design and analysis.
• Represent the biostatistics team in cross-functional meetings and contribute to strategic discussions on study design, data collection, and analysis.

Qualifications:

• Master's or Ph.D. degree in Biostatistics, Statistics, or related field.
• Minimum of 5 years of experience working as a biostatistician in a research related environment.
• Minimum of 5 years of expertise in statistical analysis software, such as SAS.
• Strong understanding of clinical trial methodology, including randomization, blinding, and endpoint determination.
• 5 years of experience with regulatory submissions (e.g., FDA, EMA) and knowledge of relevant guidelines (e.g., ICH, GCP).
• Excellent problem-solving skills and attention to detail, with the ability to critically evaluate study designs and statistical analyses.
• Effective communication skills, with the ability to explain complex statistical concepts to non-statistical stakeholders.
• Proven ability to work independently and collaboratively in a multidisciplinary team environment.