Principal/ Manager Statistician, 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.

You will be responsible for…

Study Design & Protocol Development:

· Serve as the lead statistician on clinical study teams. Provide statistical expertise for study design, sample size calculations, formulation of estimands, and authoring the statistical sections of clinical study protocols.

Statistical Analysis & Reporting

· Independently author Statistical Analysis Plans (SAPs) for clinical trials and integrated safety/efficacy summaries (ISS/ISE), ensuring the selection of the most appropriate statistical methodologies and data presentations.

· Write accurate, logical, and objective statistical method sections for Clinical Study Reports (CSRs).

· Review, interpret, and provide insightful commentary on statistical analysis results. Co-author clinical trial reports to ensure scientific rigor and accuracy of statistical interpretation.

· Ensure timely delivery of all assigned statistical work, effectively managing priorities to meet project deadlines.

Methodology & Innovation

· Drive the adoption of innovative statistical methodologies by identifying, adapting, developing, or applying optimal research techniques tailored to specific project needs.

· Communicate both routine and complex statistical concepts and results to non-statistical internal and external stakeholders in a clear, concise, and articulate manner.

Regulatory & Medical Affairs Support

· Under the guidance of senior leadership, actively participate in interactions with regulatory agencies regarding statistical issues.

· Support the development of strategic and contextually appropriate responses to requests from health authorities.

· Provide robust statistical support for medical publications, including the review of manuscripts to ensure precise and accurate statistical interpretation.

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

• Education: Ph.D. or MS in Statistics, Biostatistics, or related discipline
• Language: Fluent in English (both written and verbal)
• Experience: At least 5 years’ experience in the Pharmaceutical/Biotechnology industry in clinical development
• Industry Knowledge: Understanding of global clinical trial methodologies, CDISC standards (SDTM and ADaM), and ICH/GCP guidelines. Oncology-related experience would be preferred.
• Soft Skills:
  • Self-directed, technically strong with regard to clinical and methodological development
  • Strong analytical, problem-solving, and communication skills. Ability to work independently and collaboratively in a fast-paced matrix environment.

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
• up to 15 OPT and 12 Sick Days Annually
• Excellent Medical Coverage
• Social Security and Provident Fund
• 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 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.