SUMMARY/JOB PURPOSE:
Responsible for the development and oversight of biostatistics, and associated Biostatistics related tool and process strategies, operations, and personnel to ensure the efficient, accurate and timely collection and analysis of clinical trial data while ensuring high standards of data integrity and quality. Develops and implements company policy, practices and operating procedures in compliance with industry standards to optimize compliance, effectiveness and efficiency. Participates in establishing drug development strategy and direction.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- In collaboration with the product development teams and through subordinate management, leads the effective development and implementation of strategies consistent with the company’s strategic objectives, and ensures the overall effective operations of the biostatistics, and Biostatistics associated tools and processes
- Interacts with executive leadership to establish vision, execute decisions, manage risk, and influence activities that affect the long-term viability of the Biostatistics department and the company.
- Ensures functional areas are appropriately staffed with employees, consultants and/or temporary workers who can do, will do, and are developed to do the work necessary for the success of the functional areas and the satisfaction of the workers.
- Works with project clinicians to design, develop, conduct, and analyze Phase I – IV clinical protocols and statistical analysis plans.
- Identifies and implements appropriate statistical and data-presentation methods for regulatory and publication purposes.
- Develops productive relationships with cross functional leaders in the clinical, regulatory, drug safety, and other peer functional groups.
- Senior data science and biometrics (DSB) representative on internal executive committees including a protocol/clinical document review committee, strategic- and partner joint- development committees, and drug safety committees.
- Provides executive leadership for sponsor/CRO activities, relationships and escalation resolution.
- Interacts with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development.
- Oversees the development and implementation of best practices, SOPs, standards, work instructions and policies for biostatisticsand biostatics associated tools and processes , including novel approaches for increasing efficiency and quality, and decreasing costs and timelines.
- Responsible for selecting and managing Biostatistics key opnion leaders (KoL), Acedemic relationship, CROs and other critical vendors.
- Provided statistical leadership and strategies for Real World Data (RWD) access and analysis. Sets up and maintains statistical science and methodological team, and provides methodological guidence to the organization.
- Responsible for developing and maintaining department and biostatistics CRO budgets within corporate fiscal targets.
SUPERVISORY RESPONSIBILITIES:
- Directly supervises employees.
- Indirectly supervises employees via subordinate management.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- BA/BS in related discipline and a minimum of twenty-one years of relevant experience in the pharmaceutical industry; or,
- MA/MS in related discipline and a minimum of nineteen years of relevant experience in the pharmaceutical industry; or,
- PhD in related discipline and a minimum of seventeen years of relevant experience in the pharmaceutical industry; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
- PhD in related field strongly preferred
- In addition to educational requirement, at least 15 years progressive experience in biostatistics, including at least 8 years of progressive functional area management background through at least senior director level
- Thorough understanding of the biostatisticsfunctional areas in the therapeutic area of oncology and in the pharmaceutical industry or clinical trials unit setting.
- Successful track record of the management of clinical studies, from Phase I – III in support of US NDA filings.
- Proven ability to translate strategy into implementation that leads to results; strong track record of performance excellence meeting milestones and objectives.
- The ability to articulate a vision and strategy in a way that inspires and motivates teams to achieve results.
- Demonstrated success in collaborating and interfacing effectively with executives, advisory committees (Internal, external, and regulatory), peers, subordinates, project teams, etc., throughout the organization.
- Proven ability to deliver on measures of performance in areas of responsibility.
- Direct experience with FDA/EU regulatory authority.
