Responsible for the development and oversight of biostatistics, clinical data management, and statistical/clinical programming (BCDM) 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 thru 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, clinical data management, and clinical/statistical programming.
• Interacts with executive leadership to establish vision, execute decisions, manage risk, and influence activities that affect the long-term viability of the BCDM 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.
• Develop productive relationships with leaders in the medical, regulatory, drug safety, and other peer functional groups.
• Senior biometrics representative on internal executive committees including a protocol/clinical document review committee, strategic- and partner joint- development committees, and drug safety committees.
• Provide executive leadership for sponsor/CRO activities, relationships and escalation resolution.
• Interact with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development.
• Oversee see the development and implementation best practices, SOPs, standards, work instructions and policies for clinical data management, biostatistics and statistical programming, including novel approaches for increasing efficiency and quality, and decreasing costs and timelines.
• Responsible for selecting and managing biometrics CROs and other critical vendors.
• Responsible for developing and maintaining department and biometrics CRO budgets within corporate fiscal targets.
• Directly supervises employees.
• Indirectly supervises employees via subordinate management.
• MS/MA degree or PhD in related field strongly preferred
• In addition to educational requirement, at least 15 years progressive experience in biostatistics and clinical data management, including at least 8 years of progressive functional area management background through at least senior director level
• Thorough understanding of the biostatistics, clinical data management, and clinical/statistical programming functional 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, 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.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.