Accountabilities:

• Serve as the lead biostatistician for clinical oncology programs, developing and executing statistical strategies, study designs, analyses, and interpretations.
• Partner closely with multidisciplinary clinical development teams to establish objectives, align statistical approaches, and communicate analytical considerations throughout the trial lifecycle.
• Identify and resolve statistical and data-analysis challenges associated with clinical trials, development activities, and regulatory submissions.
• Author and own key statistical documents and deliverables, including statistical sections of protocols, Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLF) shells.
• Review study documentation and oversee the quality, accuracy, compliance, and timeliness of external vendor biometrics deliverables, including CDISC specifications and statistical outputs.
• Collaborate with statistical programmers to support regulatory requests, DSUR and Investigator's Brochure updates, ad-hoc analyses, and other development needs.
• Participate in internal reviews of ongoing clinical data and provide expert statistical interpretation to inform program decisions.
• Ensure statistical activities adhere to applicable GCP, ICH, regulatory, organizational, and standard operating procedure requirements.
• Explore and pilot AI-enabled initiatives that can strengthen quality control, improve operational efficiency, and enhance team decision-making.
• Contribute statistical expertise to global regulatory submission activities and other strategic development initiatives as needed.
• Travel approximately 10% of the time and remain available for occasional evening or weekend work based on program needs.

Requirements:

• Advanced degree in Statistics, Biostatistics, or a closely related quantitative discipline; PhD or MS required.
• At least 6 years of biostatistics experience with a PhD or 8 years with an MS, preferably within the pharmaceutical or biotechnology industry.
• Demonstrated experience serving as a lead biostatistician on clinical development programs and providing strategic statistical guidance.
• Strong knowledge of statistical methodologies and clinical trial design, with the ability to translate complex analytical findings into practical development recommendations.
• Familiarity with statistical programming environments such as SAS and/or R, along with working knowledge of CDISC standards including SDTM and ADaM.
• Ability to review, interpret, and challenge statistical programming outputs and other clinical data deliverables.
• Demonstrated experience managing or overseeing external vendors and ensuring biometrics deliverables meet quality, timeline, and compliance expectations.
• Solid understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Excellent interpersonal, written, and verbal communication skills, with the ability to influence cross-functional stakeholders and collaborate effectively across disciplines.
• Experience working successfully in highly regulated environments with strong attention to established procedures, documentation, and quality standards.
• Demonstrated experience using AI-enabled tools to improve productivity, analytical workflows, or team execution.
• Prior experience in oncology clinical development is strongly preferred.
• Experience supporting global regulatory submissions is preferred.
• Ability to work independently while effectively managing competing priorities and complex projects.

Benefits:

• Competitive salary range of $189,670–$229,834 USD for the remote U.S. position.
• Potential eligibility for additional incentive cash and stock opportunities, depending on role and eligibility.
• Medical, pharmacy, dental, and vision coverage.
• 401(k) retirement plan and financial well-being resources.
• Short- and long-term disability, life, accident, and supplemental health insurance.
• Employee assistance and well-being programs.
• Flexible paid time-off options, depending on employee classification and eligibility.
• Paid national holidays and potential additional paid sick, volunteer, parental, caregiver, bereavement, medical, personal, and military leave.
• Annual company-wide shutdown period between Christmas and New Year's Day for eligible employees.
• Potential summer-hours flexibility for eligible U.S. employees.
• Opportunities for professional growth within a collaborative, multidisciplinary life sciences environment.
• Remote work arrangement within the United States.
• Workplace accommodations and support for qualified individuals with disabilities.
• Opportunity to contribute to the development of innovative therapies addressing serious diseases and unmet patient needs.