Associate Director, Biostatistics

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Biostatistics Lead in Foster City, California. This role involves overseeing statistical analysis for clinical studies, providing statistical consultation, and managing projects in the biopharma industry. Candidates should have a strong background in statistical analysis, proficiency in SAS, and significant experience in cross-functional project management. Competitive compensation and benefits package included.

Benefits

Discretionary annual bonus

Stocks and long-term incentives

Paid time off

Medical, dental, and vision insurance

Qualifications

• 8+ years of relevant experience in statistical analysis of biomedical data.
• Minimum of 2 years of cross-functional project management or leadership experience.
• Advanced knowledge of biostatistics and related best practices.

Responsibilities

• Lead statistical analysis for clinical studies and projects.
• Provide statistical consultation on trial design.
• Review and analyze data for clinical trial monitoring.

Skills

Statistical analysis

Project management

Communication skills

SAS software proficiency

Biomedical statistical analysis

Education

MS in biostatistics or related discipline

PhD in biostatistics (preferred)

Tools

SAS

Job description

* Acting as the biostatistics lead for clinical studies or non-molecule projects, including statistical analysis, document review, and data inclusion for NDA submissions by collaborating with other biostatistics team members and cross-functional partners.* Providing statistical consultation on trial design and study endpoints, authoring statistical analysis plans, and leading projects of increasing complexity or size.* Overseeing and contributing to the completion of technical and operational statistical activities for groups of clinical trials, and directing teams in the definition, execution, and completion of statistical activities for molecules or marketed products.* Participating in cross-functional clinical development planning and protocol design discussions to provide biostatistical input.* Advising partners on statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results.* Leading the gathering, organization, and analysis of data sources to deliver special projects and statistical analysis plans for assigned products.* Reviewing and analyzing safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.* Using advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development.* Planning and documenting computer data file structures, development: Message, programming, managing, and maintaining complex statistical databases, and performing or supervising data entry.* Developing enhancements to statistical software and maintaining knowledge of current and emerging trends in statistical analysis methodologies and tools.* Providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation.* Participating in or leading special projects that benefit multiple team members, such as new methodologies, processes, technology, and tools, and contributing to the development and implementation of SOPs and related documentation.* Providing matrix management to supported projects and independently defining required resources for assigned work.* Adhering to regulatory requirements, statistical analysis principles, industry standards, and company SOPs.* MS in biostatistics or related discipline with 8+ years of relevant experience in statistical analysis of biomedical data using SAS software.* Minimum of 2 years of cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry, including multiple years of experience managing project teams.* Significant biomedical statistical analysis experience and proficiency with relevant software and tools.* Experience developing software and tools to support statistical analysis of biomedical or related data.* Proven effectiveness in managing projects and teams.* Advanced knowledge of biomedical statistical analysis, biostatistics best practices, and tools, with demonstrated ability to apply these to improve results.* Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes.* Understanding of drug development phases, clinical trials, FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures.* Strong communication and organizational skills, and ability to travel when neededPhD with 6+ years of biostatistics experience is preferred.Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans\*. For additional benefits information, visit: