Statistical Science Lead– Oncology
Lead Innovation in Clinical Development and Shape the Future of Oncology Treatments
Are you a visionary statistical expert ready to make a tangible impact on patients’ lives? We are seeking an exceptional Statistical Science Lead to join a global life sciences organization dedicated to pioneering transformative therapies in oncology. This is your chance to lead high‑stakes, complex clinical programs, influence strategic decisions, and collaborate with top‑tier stakeholders across the industry. If you thrive in dynamic environments, possess a blend of technical mastery and leadership acumen, and are eager to push the boundaries of scientific innovation, we want to hear from you.
Key Responsibilities:
- Define and drive comprehensive statistical strategies for multi-phase development programs, including early and late-stage studies.
- Serve as the primary statistical representative in cross-functional teams, fostering consensus and ensuring scientific integrity.
- Lead global regulatory interactions, preparing briefing documents and responses to health authority queries.
- Oversee the quality and consistency of statistical deliverables across studies and submissions.
- Mentoring and guiding study statisticians, promoting best practices and innovative approaches.
- Conduct complex simulations, modeling, and analyses to support decision-making and regulatory filings.
- Collaborate with clinical, medical affairs, and biomarker teams, ensuring robust interim analysis plans, data monitoring strategies, and go/no-go decision frameworks.
- Contribute strategic insights to Clinical Development Plans, influencing trial design and development trajectories.
Required Skills:
- Extensive experience in clinical development, including study design, regulatory submissions, and statistical methodologies.
- Proven ability to independently lead projects across the full lifecycle, from early to late-phase studies.
- Strong expertise in adaptive designs, simulations, and modeling techniques.
- Excellent cross-functional communication skills with the ability to influence and negotiate with stakeholders.
- Hands‑on recent experience working within a pharmaceutical environment, with a focus on oncology.
- Bachelor’s degree minimum; MSc or PhD in Biostatistics, Statistics, or a related scientific field.
- Deep knowledge of SAS (required) and R (preferred), with a solid understanding of data management and programming processes.
Nice to Have Skills:
- Experience working in both CRO and pharma settings.
- Prior involvement in global regulatory interactions and submissions.
- Familiarity with biomarker data, PK/PD analyses, and innovative statistical methodologies.
- Engagement with external industry organizations or academic institutions to stay at the forefront of statistical innovation.
Preferred Education & Experience:
- PhD or MSc complemented by significant (usually 9+ years for PhD or 12+ years for MSc) relevant experience in applied biomedical statistics.
- Demonstrated leadership in complex clinical projects within the oncology space.
- Recent hands‑on experience in study design, simulation, and regulatory interactions.
Other Requirements:
- Certifications in biostatistics or related professional memberships are advantageous but not mandatory.
Take the next step in your career and drive innovation in cancer research — apply now to be part of a forward‑thinking organization committed to transforming patient outcomes worldwide.
