Senior Director, Biostatistics

Who we are…

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

What you’ll be doing

The Senior Director of Biostatistics will lead the strategic and operational statistical activities across multiple clinical development programs. This role requires deep expertise in clinical trial design, regulatory strategy, and cross-functional leadership. The Senior Director will serve as a key contributor to regulatory submissions, data interpretation, and innovation initiatives, while managing a team of biostatisticians and collaborating with internal and external stakeholders.

You will be responsible for…

Strategic Leadership

• Define and execute statistical strategies for early to late-phase clinical trials.
• Lead biostatistics input for Clinical Development Plans, regulatory interactions, and submission packages.
• Represent Biostatistics in cross-functional leadership forums and project teams.

Operational Excellence

• Oversee study design, protocol development, SAP creation, and endpoint selection.
• Guide statistical analysis, interpretation, and reporting of clinical trial data.
• Ensure quality and compliance with ICH, FDA, and GCP guidelines.

Team Management

• Manage and mentor a team of biostatisticians, fostering technical growth and leadership development.
• Lead vendor selection and oversight for outsourced statistical services.

Regulatory Engagement

• Prepare for and participate in regulatory meetings (e.g., EoP2, Advisory Committees).
• Provide statistical responses to regulatory queries and support submission documentation.

Innovation & Collaboration

• Drive innovation in statistical methodologies and analytics tools (e.g., RShiny apps, innovative trial design).
• Collaborate with Programming, Data Management, Clinical Operations, Clinical Research, and Medical Affairs.

What Knowledge & Experience you'll bring to us...

• PhD in Biostatistics, Statistics, or related field (Master’s with extensive experience may be considered).
• Minimum 10 years of experience in clinical trial statistics within the pharmaceutical or biotech industry.
• Proven leadership in strategic planning, regulatory submissions, and cross-functional collaboration.
• Expertise in SAS, R, CDISC standards (SDTM, ADaM), and statistical software (e.g., EAST).
• Strong communication and presentation skills with ability to influence across functions.
• Experience managing teams and mentoring junior staff.

Behavioral skills to be successful...

• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence, curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

What we have for you!

• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• and much more!

The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.

Disclaimer

Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This job description reflects 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 this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.

Flexible work from home options available.