Vice President, Biostatistics

Exelixis Inc; Alameda (CA); On-site; USD 360,000 - 418,000; Full time

Benefits offered by this job

401(k) plan

Medical coverage

Life insurance

Discretionary bonus

Stock options

Paid time off

Holidays

Job summary

Exelixis Inc is seeking a senior biostatistics leader to oversee development and governance of biostatistics strategy, tools and processes for clinical trial data. You will ensure data integrity and regulatory readiness while shaping drug development direction.

The role partners with executive teams, vendors and CROs to design studies, oversee regulatory submissions, and drive efficiency. Strong leadership, FDA/EU experience, and a track record of delivering Phase I–III programs are essential.

Qualifications

• PhD or equivalent in biostatistics with extensive pharma industry experience.
• Proven track record of leading biostatistics teams and delivering regulatory submissions.
• Strong leadership and communication across cross-functional teams.

Responsibilities

• Lead development and implementation of biostatistics strategies aligned with corporate objectives.
• Interact with executive leadership to set vision and manage risk for Biostatistics.
• Ensure staffing for critical work across departments.
• Collaborate with project clinicians to design and analyze Phase I–IV trials.
• Advise on regulatory submissions and data presentation methods.
• Provide statistical leadership for Real-World Data analysis.
• Set up and maintain methodological teams and budget planning.

Skills

Biostatistics leadership

Regulatory knowledge

Statistical methods

Cross-functional collaboration

FDA interactions

Team management

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

Regulatory analytics tools

Job description

Summary

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

• Lead the effective development and implementation of strategies consistent with the company’s strategic objectives, ensuring overall effective operations of the biostatistics and associated tools and processes.
• Interact 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.
• Ensure functional areas are appropriately staffed with employees, consultants and/or temporary workers to perform critical work.
• Work with project clinicians to design, develop, conduct, and analyze Phase I–IV clinical protocols and statistical analysis plans.
• Identify and implement appropriate statistical and data‑presentation methods for regulatory and publication purposes.
• Develop productive relationships with cross‑functional leaders in the clinical, regulatory, drug safety, and other peer functional groups.
• Act as senior data science and biometrics representative on internal executive committees, including protocol and clinical document review, strategic and partner development, 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 maintain ongoing agreement on project development.
• Oversee development and implementation of best practices, SOPs, standards, work instructions and policies for biostatistics and associated tools and processes, including novel approaches for increasing efficiency and quality while reducing costs and timelines.
• Select and manage Biostatistics key opinion leaders, academic relationships, CROs and other critical vendors.
• Provide statistical leadership and strategies for Real‑World Data (RWD) access and analysis.
• Set up and maintain statistical science and methodological team and provide methodological guidance to the organization.
• Develop and maintain department and biostatistics CRO budgets within corporate fiscal targets.

Supervisory Responsibilities

Directly supervise employees; indirectly supervise employees via subordinate management.

Education, Experience and Knowledge & Skills

• Education: BA/BS in a related discipline with at least 21 years of relevant experience in the pharmaceutical industry, or MA/MS with at least 19 years, or PhD with at least 17 years, or an equivalent combination of education and experience.
• PhD in a related field strongly preferred.
• At least 15 years of progressive experience in biostatistics, including at least 8 years of progressive functional area management through at least senior director level.
• Thorough understanding of biostatistics functional areas in oncology and the pharmaceutical industry or clinical trials unit setting.
• Successful track record of managing clinical studies from Phase I–III supporting U.S. NDA filings.
• Proven ability to translate strategy into implementation that leads to results; strong track record of performance excellence meeting milestones and objectives.
• Ability to articulate a vision and strategy that inspires and motivates teams.
• Demonstrated success in collaborating and interfacing with executives, advisory committees, peers, subordinates, and project teams.
• Direct experience with FDA/EU regulatory authority.
• Strong leadership and communication skills.

Compensation

The base pay range for this position is $360,000 – $418,000 annually. Pay may vary by geographic region and will be adjusted based on location, job‑related knowledge, skills, experience, and internal equity. The base pay offered will include the candidate’s geographic region, job‑related knowledge, skills, experience and internal equity, among other factors.

Benefits

• 401(k) plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Opportunity to purchase company stock and receive long‑term incentives.
• 15 accrued vacation days in the first year; 17 paid holidays including a company‑wide winter shutdown in December; up to 10 sick days per calendar year.

Working Conditions

The office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. All necessary equipment, including dual monitors and ergonomic chairs, is provided to ensure a comfortable workspace.

Disclaimer

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.

Equal Employment Opportunity

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, or basis of disability or any other federal, state or local protected class.