Director, Biostatistics

Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.
**About This Role**:
Veranex has an exciting opportunity to join our team as a Director of Biostatistics. You will be part of a team working to improve lives globally through medical technology innovation. The Director, Biostatistics will be responsible for the quality and consistency of key statistical deliverables while providing sound strategic, scientific, and statistical leadership to the organization for clinical studies. Manages and oversees Biostatistics team including appropriate staff resourcing and assignments, quality control and timely delivery of project deliverables.
**What You Will Do**:

- Responsible for all statistical tasks on assigned clinical trials across multiple sponsor projects, seeking peer review/input when necessary. Oversee protocol development in alignment with sponsor needs, develop statistical analysis plans, and lead study
- and indication-level reporting activities.
- Proactively drive and implement novel statistical methods, innovative trial designs, and dose-finding strategies in collaboration with the Lead Statistician and clients.
- Independently manage interactions with external review boards, ethics committees, consultants, and other stakeholders, including client oversight, ensuring appropriate statistical expertise is applied. Represent the CRO in statistical discussions at international congresses, conferences, and scientific meetings, and act as the primary biostatistics contact for sponsors.
- Serve as a key representative of the Biostatistics function on cross-functional teams for assigned clinical trials, ensuring alignment between CRO and client requirements, and raising awareness of biostatistical needs within project teams.
- Collaborate effectively with other functional areas (e.g., clinical operations, data management, programming) to ensure smooth project execution. Explain complex statistical concepts for non-statisticians, including clients, and provide clear justifications and interpretations of results to guide decision-making processes.
- Build and maintain strong collaborative relationships and effective communication with both internal project teams and external clients to ensure the delivery of high-quality biostatistical services.
- Oversee the allocation of Biostatistics resources across multiple projects and manage the timely delivery of high-quality Biostatistics outputs for assigned clinical and non-clinical activities. Ensure execution within budget, promote efficient management of resources, and mentor the team to foster their professional growth and development.
- Manages and develops the team to ensure performance meets and/or exceeds business and personal goals and objectives
- Prepares reports, status updates, escalations, and communication for leadership. Interacts with senior leadership and major stakeholders to establish strategic plans and objectives for programs and projects
- Serves as point of escalation for resolution of issues
- Significantly contributes to business development initiatives, including presentations and proposal development

**Qualifications**:Required skills**:

- MS in Statistics with at least 10 years of relevant work experience in a CRO, or PhD in Statistics (or equivalent) with 6+ years of relevant work experience in a CRO environment.
- Fluent in English with excellent communication and presentation skills, capable of conveying complex statistical concepts to diverse audiences, including sponsors.
- Proven knowledge and expertise in clinical trial statistics, with experience in medtech or medical device studies strongly preferred. Expertise in areas such as Bayesian statistics, exploratory biomarkers, and diagnostic analyses depending on the specific trial requirements.
- Proficient in statistical software packages such as SAS and R, with hands-on experience leading client interactions and guiding clinical development strategies for diverse sponsors.
- Demonstrated ability to provide statistical expertise during regulatory submission activities, including preparing submission documents, meetings with Health Authorities, and responding to client-specific regulatory inquiries.
- Strong understanding of multiple therapeutic areas and their associated regulatory activities, with strong experience in medical devices.
- Excellent scientific leadership, with a proven ability to optimize clinical development strategies and trial design methodologies across various client projects.
- Demonstrated capability to build and foster partnerships with clients, internal stakeholders, and external collaborators, with the ability to mentor and develop the team.

**Preferred**:

- Experience in both pharma and medical device studies