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# VP of Biostatistics and Data Management – Clinical Research Organization – Durham, NC


 
VP of Biostatistics and Data Management – Clinical Research Organization
Are you a strategic leader with deep expertise in biostatistics, data management, and clinical research operations? We are seeking a Vice President of Biostatistics and Data Management to join a fast-growing Clinical Research Organization (CRO) headquartered in Durham, NC. In this executive role, you will shape statistical strategy, enhance data integrity, and guide teams that support global clinical development programs. If you excel at translating complex data into meaningful decision-driving insights and thrive in a high-impact, regulated environment, this role offers an opportunity to lead critical initiatives that influence patient outcomes and scientific advancement.
Lead Biostatistics & Data Operations for a Growing CRO in Durham, NC
A leading Clinical Research Organization in Durham, NC is actively searching for a VP of Biostatistics and Data Management to oversee statistical methodologies, clinical data standards, and cross-functional data operations. The ideal candidate brings extensive experience managing biostatistics and data management teams within a CRO or pharmaceutical setting, with a strong record of ensuring regulatory compliance, statistical accuracy, and database quality. If you are passionate about team leadership, clinical data excellence, and guiding innovative clinical development strategies, this is a rare chance to make a significant impact on global healthcare initiatives.
Key Responsibilities of the VP of Biostatistics and Data Management – Clinical Research Organization
Strategic Statistical Leadership:
Provide strategic direction for all biostatistics and clinical data management activities. Define the overall statistical vision and ensure alignment with clinical development goals, regulatory expectations, and organizational priorities.
Clinical Data Strategy & Oversight:
Lead the development and execution of data management strategies to support clinical trials across multiple phases and therapeutic areas. Ensure high-quality, compliant, and audit-ready clinical databases.
Regulatory Compliance & Submission Support:
Oversee statistical deliverables and documentation for regulatory submissions, including protocols, SAPs, CSR outputs, and CDISC-compliant data sets. Ensure all activities meet FDA, EMA, ICH, and GCP requirements.
Cross-Functional Collaboration:
Work closely with clinical operations, medical writing, pharmacovigilance, and project management teams to ensure data integrity and streamline study execution. Serve as the primary biostatistics and data expert during internal and external meetings.
Operational Excellence & Process Improvement:
Implement best practices, modern analytics platforms, and automation opportunities to improve data workflows, reduce cycle times, and increase accuracy and efficiency across biostatistics and data functions.
Team Leadership & Talent Development:
Lead, mentor, and grow a high-performing biostatistics and data management team. Promote a culture of scientific rigor, accountability, innovation, and collaboration across departments.
Vendor & Budget Management:
Manage relationships with external CROs, technology partners, and data vendors. Oversee budgets, resource allocation, and capacity planning to support current and future studies.
Risk Mitigation & Data Quality Assurance:
Anticipate data and statistical risks across studies and implement proactive solutions. Ensure robust data validation, quality review, and consistency across clinical trial deliverables.
Advanced Data Analytics & Innovation:
Drive innovation by adopting emerging technologies, data visualization tools, and modern analytics techniques to elevate clinical data interpretation and decision-making.
Executive Reporting & Stakeholder Communication:
Provide clear, data-driven updates to executive leadership, scientific committees, and sponsors. Communicate statistical insights that support strategic clinical development decisions.
What the Client is Looking for in You
As the VP of Biostatistics and Data Management, the client seeks an accomplished leader with a proven ability to oversee biostatistics strategy, clinical data operations, and regulatory deliverables within a fast-paced Clinical Research Organization (CRO) environment. You should bring deep scientific expertise combined with strong operational leadership to ensure high-quality statistical outputs and efficient data management processes that support successful clinical trials.
Expertise in Biostatistics and Clinical Data Leadership
The ideal candidate has extensive experience leading biostatistics and data management teams within a CRO, pharmaceutical company, or biotech organization. You must be skilled in developing and executing statistical strategies, managing clinical databases, and ensuring data accuracy across multiple trial phases. Demonstrated success in statistical planning, protocol development, and overseeing CDISC-compliant datasets is highly valued.
Strategic Thinker with Regulatory & Submission Experience
To succeed as the VP of Biostatistics and Data Management, you should be able to design and implement long-term data strategies that support regulatory submissions and clinical development timelines. The client values leaders who understand the complexities of working with global regulatory authorities (FDA, EMA, ICH) and can anticipate potential risks while proactively driving solutions.
Strong Analytical and Technical Proficiency
You must have hands-on expertise with biostatistical tools, data management platforms, and emerging technologies. Proficiency with SAS, R, CDISC standards (SDTM, ADaM), and modern EDC systems is essential. The client seeks someone who leverages advanced analytics and data visualization to inform decision-making and optimize clinical trial outcomes.
Leadership Excellence & Team Development
Leadership is central to this role. The client is looking for a candidate who can mentor, develop, and inspire high-performing teams across biostatistics and data management functions. You should foster an environment rooted in collaboration, accountability, and scientific rigor, while ensuring team members have clear development paths and continuous learning opportunities.
Effective Stakeholder Communication
You must be able to communicate statistical insights clearly to cross-functional teams, executives, external partners, and regulatory agencies. The ideal candidate can translate complex clinical data into concise, actionable guidance for decision-makers.
Commitment to Quality, Compliance & Operational Excellence
The client values a leader who prioritizes data integrity, process improvement, and regulatory compliance. A strong understanding of clinical trial governance, risk mitigation, and inspection readiness is crucial. Your ability to implement best practices and optimized workflows will be key to operational success.
FAQs About the Role – VP of Biostatistics and Data Management – Clinical Research Organization
1. What are the key responsibilities of the VP of Biostatistics and Data Management?
As the VP of Biostatistics and Data Management, you will oversee statistical strategy and clinical data operations, ensuring the accuracy, integrity, and regulatory compliance of all clinical trial data. You will lead cross-functional collaboration, manage global regulatory submissions, and guide high-performing teams responsible for biostatistics, data management, and analytical reporting throughout the clinical study lifecycle.
2. What qualifications and experience are required for this position?
The ideal candidate should have senior-level experience in biostatistics and data management within a CRO, pharmaceutical, or biotech environment. A master’s or PhD in Biostatistics, Statistics, or a related field is preferred, along with proficiency in SAS, R, CDISC standards (SDTM/ADaM), and EDC systems. Experience leading clinical data strategies, regulatory submissions, and large cross-functional teams is essential for success as the VP of Biostatistics and Data Management.
3. What leadership qualities are essential for this role?
You must be a strategic thinker with strong communication and decision-making skills. The client seeks a leader who can inspire and mentor teams, prioritize data-driven decision-making, and collaborate effectively with stakeholders across clinical operations, regulatory affairs, and executive leadership.
4. What challenges can I expect in this role?
You may encounter challenges such as managing tight regulatory timelines, integrating complex datasets, ensuring inspection readiness, and anticipating risks across global studies. As the VP of Biostatistics and Data Management, you will need to balance strategic leadership with hands-on problem solving to ensure high-quality, compliant deliverables.
5. How does this role impact clinical trial success and company growth?
Your leadership will directly influence trial efficiency, data integrity, and regulatory approval outcomes. By driving statistical excellence and streamlined data processes, you will contribute to faster decision-making, improved clinical development timelines, and broader company growth.
6. What is the company’s culture and work environment like?
The organization fosters a collaborative, fast-paced, and innovation-oriented environment. Team members are valued for their expertise, transparency, and commitment to quality. As a leader, you will help shape and reinforce a culture centered around scientific rigor, accountability, and continuous improvement.
What Remuneration Can You Expect from This Job?
As the VP of Biostatistics and Data Management at a leading Clinical Research Organization in Durham, NC, you can expect a highly competitive and comprehensive compensation package designed to attract top-tier scientific and data leadership talent. Compensation for this executive role typically includes the following components:
1. Base Salary
The base salary for a VP of Biostatistics and Data Management varies depending on company size, scope of responsibility, and level of expertise. For a CRO operating in a competitive life sciences market, the annual base salary commonly ranges between $250,000 and $350,000, with top industry leaders potentially earning higher.
2. Annual Performance-Based Bonuses
In addition to a strong base salary, most compensation packages include annual bonuses tied to key organizational and project performance metrics. Bonus opportunities may range from 25% to 50% of the base salary, depending on individual contributions to clinical trial success, operational efficiency, and regulatory milestones.
3. Equity, Stock Options & Long-Term Incentive Plans (LTIPs)
To align leadership performance with company growth, many CROs offer equity-based incentives, including stock options or performance shares. These long-term rewards allow the VP of Biostatistics and Data Management to directly benefit from the organization’s continued expansion and valuation growth.
4. Executive Benefits & Perks
Executives in this role typically receive an extensive suite of benefits, which may include:

Comprehensive medical, dental, and vision insurance
401(k) with company matching or pension plan
Life, disability, and supplemental insurance coverage
Paid time off and executive-level leave policies
Professional development opportunities and conference allowances

Some companies may also offer wellness reimbursements, travel allowances, and technology stipends.
5. Signing Bonus & Relocation Assistance (If Applicable)
For highly qualified candidates, especially those relocating to Durham, NC, companies may offer a signing bonus or relocation support to facilitate a smooth transition.
Total Compensation Potential
When combining base salary, annual bonuses, equity, and incentive plans, total compensation for a VP of Biostatistics and Data Management can range from $350,000 to $550,000+ annually, depending on company performance and experience level.
How to Apply
If you are a data-driven, strategic leader with a proven track record in clinical trial biostatistics and data operations, we invite you to apply for the VP of Biostatistics and Data Management position based in Durham, NC. This is an exceptional opportunity to lead critical statistical and data management functions within a high-growth Clinical Research Organization and directly influence clinical development success.
To apply, please submit your resume along with a cover letter highlighting your experience in:

Leading biostatistics and data management teams in a CRO, biotech, or pharmaceutical environment
Regulatory submission support (FDA, EMA, ICH) including CDISC standards (SDTM/ADaM)
Clinical data strategy, process optimization, and implementation of biostatistical methodologies
Cross-functional collaboration, stakeholder communication, and team leadership

Be sure to emphasize your experience managing large datasets, ensuring data integrity, driving statistical strategy, and your ability to lead in dynamic, fast-paced clinical research settings.
This executive role offers a high-impact opportunity to shape statistical strategy, drive operational excellence, and contribute to the advancement of clinical development. Take the next step in your scientific leadership career and apply today for the VP of Biostatistics and Data Management role in Durham, NC.
For more information or to explore similar executive roles in clinical research, connect with our Biometrics Executive Search Firm Team.
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VP of Biostatistics and Data Management | Biostatistics Executive Jobs | Clinical Research Organization Leadership | Clinical Data Strategy | CRO Executive Recruitment | Life Sciences Leadership Roles