Associate Director, Biostatistics - Immunology
Scorpion Therapeutics, Blairstown, New Jersey, United States
Role Summary
Associate Director, Biostatistics - Immunology. This role leads the Biostatistics department in Global Development, partnering with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, design clinical experiments, and analyze results to inform decisions. The incumbent represents statistical issues in regulatory meetings, develops training and infrastructure, and mentors statisticians, with the potential to manage staff. Responsibilities
Lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints, frame statistical approaches, design clinical experiments and interventional studies, and analyze resulting data. Represent statistical issues in regulatory agency meetings and contribute to regulatory interactions, including drafting analysis plans and reviewing materials for regulatory meetings. Lead training for non-statistical colleagues and contribute to the development of new infrastructure and processes; participate in cross-functional workstreams and author or revise SOPs. Evaluate software options for planned analyses and identify needs for novel statistical methodologies or tools. Prepare presentations and written reports to communicate results to project teams, management, and regulatory agencies; co-present findings to management. Mentor and oversee less experienced statisticians, with potential to manage full-time staff. Engage in research activities for innovative statistical methods and applications in clinical trial development and provide training to non-statisticians. Qualifications
PhD or equivalent degree in statistics/biostatistics with >6 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >11 years’ experience. Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies. Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. Ability to work productively in a fast-paced collaborative environment, with strong critical thinking skills, time management skills, and effective communication skills. Solid knowledge of statistical analysis methodologies and experimental and clinical trial design. Expertise in statistical software such as R or SAS. Skills
Leadership and cross-functional collaboration Strategic thinking and problem solving in a regulatory context Excellent communication and presentation skills Proficiency in R and SAS Knowledge of statistical analysis methodologies and trial design
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Associate Director, Biostatistics - Immunology. This role leads the Biostatistics department in Global Development, partnering with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, design clinical experiments, and analyze results to inform decisions. The incumbent represents statistical issues in regulatory meetings, develops training and infrastructure, and mentors statisticians, with the potential to manage staff. Responsibilities
Lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints, frame statistical approaches, design clinical experiments and interventional studies, and analyze resulting data. Represent statistical issues in regulatory agency meetings and contribute to regulatory interactions, including drafting analysis plans and reviewing materials for regulatory meetings. Lead training for non-statistical colleagues and contribute to the development of new infrastructure and processes; participate in cross-functional workstreams and author or revise SOPs. Evaluate software options for planned analyses and identify needs for novel statistical methodologies or tools. Prepare presentations and written reports to communicate results to project teams, management, and regulatory agencies; co-present findings to management. Mentor and oversee less experienced statisticians, with potential to manage full-time staff. Engage in research activities for innovative statistical methods and applications in clinical trial development and provide training to non-statisticians. Qualifications
PhD or equivalent degree in statistics/biostatistics with >6 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >11 years’ experience. Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies. Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment. Ability to work productively in a fast-paced collaborative environment, with strong critical thinking skills, time management skills, and effective communication skills. Solid knowledge of statistical analysis methodologies and experimental and clinical trial design. Expertise in statistical software such as R or SAS. Skills
Leadership and cross-functional collaboration Strategic thinking and problem solving in a regulatory context Excellent communication and presentation skills Proficiency in R and SAS Knowledge of statistical analysis methodologies and trial design
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