Vice President II, Data & Statistical Sciences

Role Summary

The Vice President II, Data & Statistical Sciences will oversee biostatistics, statistical and clinical programming, data management and data science strategies, including system and process implementation, data science operations and personnel. The Vice President II will have accountability for data integrity, accuracy and timely collection in clinical trials and is expected to drive innovation to further impact drug development and data delivery. The Vice President II will develop and implement company policies, practices and operating procedures in agreement with industry standards to optimize effectiveness, efficiency and compliance.

Responsibilities

• Lead, develop, inspire and optimize the capabilities of our biostatistics, statistical and clinical programming, data management, and data science teams.
• Interact with executive leadership to align on vision and influence activities that affect the long-term success of Data and Statistical Sciences at Exelixis.
• Ensure the overall effective operations of data sciences.
• Provide leadership and oversight to the design and development of Phase I-IV clinical protocols and their associated statistical analysis plans, and to the design and development of analytical and data standards.
• Acts as senior representative on internal executive committees, strategic and partner joint-development committees, and drug safety committees.
• Provide executive leadership and guidance on CRO activities related to data and statistical sciences.
• Lead critical interactions internally and with relevant Health Authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing alignment on project deliverables.
• Oversee the development and implementation of best practices, SOPs, standards, work instructions, and policies for biostatistics, statistical programming, data science and data management including novel approaches for increasing efficiency and quality.
• Serve as and interact with key opinion leaders in the industry.
• Oversee the selection and management of data science vendors, not limited to CROs, FSPs, consultants and temps such that corporate strategies and goals are achievable.
• Develop and maintain department headcount and budgetary needs.
• Develop and promote a supportive workplace culture that values diversity of thought, integrity and accountability, and support talent development, coaching and leadership succession.

Supervisory Responsibilities

• Directly supervises employees as well as indirectly influence employees via subordinate management.

Education

• PhD in a related field and 20 years of related experience; or,
• Equivalent combination of education and experience.

Experience

• 20 years of progressive experience in biostatistics, including at least 10 years of progressive functional area management background through Vice President level (or equivalent scope).
• Demonstrated success in collaborating and interfacing effectively with executives, advisory committee, peers, subordinates, project teams, etc. throughout the organization.
• Extensive experience in interacting with regulatory authorities.
• Strong leadership, communication and interpersonal skills.
• Strong business acumen with ability to drive profitability and operational efficiency.
• Strategic thinker with a proven ability to innovate in science and drug development and a track record of delivering on goals and accountabilities.

Knowledge, Skills And Abilities

• Comprehensive understanding of the biostatistics and clinical/statistical programming functional areas in the therapeutics areas of oncology and in the pharmaceutical industry or clinical trials unit setting.
• Successful track record of the management of clinical studies, from Phase I-IV in support of regulatory filings.
• Advanced knowledge of innovative clinical trial designs, basic understanding of oncology/hematology and associated endpoints for regulatory approval.
• 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.
• This is an office position.
• Travel is required.