Senior Director of Biostatistics

This is an exciting opportunity to independently lead a team of statisticians advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Senior Director of Biostatistics, you will leverage your clinical statistics expertise to oversee the strategic design, analysis, and reporting for multiple practice-changing oncology clinical trials. The ideal candidate brings exceptional leadership and communication skills, a trusted and scientifically grounded perspective, and a comprehensive understanding of clinical biostatistics in an oncology setting. 

PRIMARY RESPONSIBILITIES:

• Team Leadership: Build, mentor, and direct a high-performing clinical biostatistics team. Foster collaboration, and oversee both the technical and professional development of team members.

• Study Design and Analysis: Lead the strategic planning, statistical analysis, and interpretation of interventional clinical studies.

• Cross-Functional Collaboration: Partner with medical, clinical, translational, and regulatory teams to apply statistical expertise in study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including protocols, statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Regulatory Compliance: Ensure statistical methodologies and analyses adhere to applicable regulator standards set by regulatory agencies such as the FDA.

• Innovation and Improvement: Provide strategic direction on the use of both established and emerging statistical methodologies, adapting approaches to match study complexity and regulatory context.

• Strategic Leadership: Drive continuous improvement in team efficiency and analytical rigor. Promote departmental standards for statistical analysis and ensure alignment with broader organizational and regulatory objectives.

QUALIFICATIONS:

• Minimum 13 years relevant clinical experience, with a focus in oncology in pharmaceutical or related biotech industries. At least 8 years leading a team.

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. 

KNOWLEDGE, SKILLS, AND ABILITIES:

•  Proven track record of hiring, mentoring, and developing high-performing teams of statisticians

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges

• Extensive experience with interventional, multi-faceted clinical study designs, sample size determination, and advanced analytical methods

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds

• Skilled in producing high quality written documentation tailored to a range of audiences

• Exceptional problem-solving skills, strategic innovation, and attention to detail

• Outstanding communication, influencing, and analytical skills across all levels of an organization