Statistical Science Director

Job DetailExperience Level DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type On SiteJob Reference 0000020184Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful statistical strategies in pharmaceutical development. Collaborate across functions to drive regulatory success and innovation. Mentor teams and implement novel methodologies for industry advancement.Job DescriptionStatistical Science Director OverviewAs a Statistical Science Director, lead statistical strategies and technical activities in pharmaceutical development.Collaborate across functions to design, deliver, and interpret data for regulatory submissions and governance committees.Mentor and develop statistical staff, fostering technical expertise and professional growth within the team.Apply novel statistical methodologies to address complex issues and enhance decision-making processes.Represent the organization externally at conferences, workshops, and health authority interactions.Contribute to the development plans, regulatory strategies, and health technology assessments for product indications.Ensure statistical content quality for study designs, documents, delivery, interpretation, and submissions.Lead global statistical strategies and direct project work delivered by internal and external teams.Stay updated on statistical methodologies and implement innovative approaches in pharmaceutical research.Statistical Science Director Key Responsibilities & DutiesLead statistical design and strategy for product development plans and regulatory submissions.Provide statistical leadership and ensure compliance with standards and regulations.Quantify benefit, risk, value, and uncertainty of emerging product profiles.Collaborate with cross-functional teams to deliver high-quality decision support.Mentor and coach statistical staff, promoting technical education and training.Partner with CROs to ensure timely and quality delivery of statistical work.Represent statistical strategy in internal governance and therapy area leadership teams.Investigate and implement novel statistical approaches for regulatory and methodological advancements.Maintain expertise in statistical methodologies and contribute to external collaborations and publications.Statistical Science Director Job RequirementsDoctorate in Statistics, Mathematics, or related field with substantial statistical components.Minimum 5 years of experience in clinical trials and statistical leadership.Proficiency in programming languages like SAS, R, and Python.Recognized expertise in statistical methodologies and regulatory interactions.Experience in vaccines and immunotherapy is preferred but not required.Strong project management and communication skills for cross-functional collaboration.Ability to lead and direct work across teams, ensuring quality and compliance.National recognition as a statistical technical expert with relevant publications.Experience in business development opportunities, such as in-licensing, is beneficial.