As a Senior Biostatistician, you will lead and innovate in the analysis of clinical study data, clinical laboratory data, and product development efforts. This pivotal role demands a blend of expertise in bioinformatics, data mining, sophisticated database queries, and advanced statistical analysis to drive evidence-based decisions. Your contributions will be critical in shaping our scientific approaches and product development strategies.

Location note: This is a hybrid role and requires on-site work at our Carlsbad office. Candidates must live within commuting distance.

Responsibilities

Note: Other duties may be assigned.

• Lead Statistical Analysis Efforts: Design and implement advanced statistical analysis strategies to support clinical studies and product development. This includes working with large datasets, conducting routine monitoring and quality controls of clinical laboratory data, and performing data analyses for experiments and projects, particularly in the planning stage.
• Collaboration and Communication: Serve as a statistical liaison to project teams, including R&D and clinical laboratories, ensuring effective communication and collaboration. Work closely with scientific staff within and outside the R&D group, including academic collaborators, external consultants, and scientists, to align on research goals and methodologies.
• Data Mining and Quality Control: Lead efforts in data mining and the development of complex database queries to extract actionable insights from clinical study data. Conduct routine monitoring and quality controls to ensure data integrity and compliance with regulatory standards.
• Scientific Writing and Presentations: Aid in the writing of scientific publications for peer-reviewed journals and present findings at conferences, in collaboration with academic and industry partners. Maintain accurate and comprehensive records of methodologies and analyses to support publication efforts.
• Mentorship and Leadership: Mentor junior biostatisticians and statistical programmers, promoting a culture of excellence, innovation, and continuous improvement. Share expertise and knowledge to enhance team capabilities and support professional development.
• Compliance and Confidentiality: Ensure all activities comply with company SOPs, safety standards, and ethical guidelines, including maintaining the confidentiality of customer and patient information.
• Strategic Planning: Interface with project teams across the organization, including the R&D group and clinical laboratory, to provide statistical expertise that guides research direction and product development decisions.
• Ad Hoc Responsibilities: Perform other related duties as needed and required by supervisors, demonstrating flexibility and the ability to adapt to changing project needs and company priorities.

Minimum Qualifications:

• Possess an M.S. or Ph.D. degree in Biostatistics, Bioinformatics, Statistics, or a closely related field or equivalent years of experience.
• Demonstrated ability to work both independently and collaboratively within interdisciplinary research groups. Candidates must be capable of leading projects as well as contributing as a valuable team member.
• A strong technical and theoretical background in data analysis methods, with a focus on experimental design, particularly related to diagnostic tests. This includes understanding the complexities and nuances of clinical data.
• Hands-on experience with data processing and analytics, as well as statistical analysis software packages (e.g., R, Python). Proficiency in Excel and SQL is a must.
• Proficient in managing databases (e.g., SQL Server, MySQL) and familiar with server environments (Windows, Linux). This skill set supports the management of large datasets and computational analyses.
• Must possess excellent communication skills, with the ability to articulate complex statistical concepts and analysis results clearly and effectively to both statistical and non-statistical audiences.
• Demonstrated problem-solving skills and the capacity to approach challenging research questions with innovative solutions.

Preferred Qualifications:

• Demonstrated experience with scientific publications in peer-reviewed journals. A track record of contributing to scientific literature, especially in the field of biostatistics or related disciplines.
• Expertise in advanced statistical methods, including machine learning and predictive modeling, as applied to clinical data analysis. Familiarity with Bayesian statistics or other specialized statistical methodologies would be advantageous.
• Experience leading statistical components of clinical research projects, including the design, analysis, and interpretation phases. Ability to guide junior statisticians and cross-functional team members through complex analyses.
• Familiarity with regulatory standards and guidelines relevant to clinical research and diagnostic testing (e.g., CLIA/CAP). Experience preparing statistical analysis plans and reports for regulatory submissions would be beneficial.
• Skills in software development or significant contributions to statistical software packages. Proficiency in additional programming languages (e.g., Python) or experience with software development practices (version control, testing, documentation) is highly desirable.
• Advanced skills in data visualization and the ability to communicate complex results through graphical representations. Experience with visualization tools and libraries (e.g., Tableau, ggplot2 in R, Power BI).
• A history of collaborative research, including working with interdisciplinary teams, external academic groups, and industry partners. Ability to foster productive partnerships and effectively manage collaborations.
• A commitment to continuous professional development and staying abreast of new technologies, statistical techniques, and industry trends. Demonstrated ability to apply innovative solutions to research challenges.

Salary range: $110,000 - $145,000