Sr. Manager, Biostatistics

About the role

As a Sr. Manager of Biostatistics at Structuretx, you will play a role in advancing our mission to develop innovative therapies for patients with serious diseases. This position requires a blend of statistical expertise, leadership capabilities, and a passion for biostatistics in the biopharmaceutical industry. You will be responsible for overseeing statistical analyses, guiding a team of biostatisticians, and collaborating closely with cross-functional teams to ensure the integrity and accuracy of clinical trial data. Your contributions will directly impact the development of treatments, making this an for a driven professional.

Key facts

What you'll do

• Lead and mentor a team of biostatisticians, fostering a collaborative environment that encourages professional growth and innovation.
• Oversee the design and analysis of clinical trials, ensuring that statistical methodologies are and aligned with regulatory standards.
• Collaborate with clinical development teams to define statistical analysis plans (SAPs) and ensure that they are executed effectively throughout the trial lifecycle.
• Provide statistical input for clinical study protocols, informed consent documents, and regulatory submissions, ensuring clarity and compliance with industry standards.
• Analyze complex datasets using advanced statistical techniques, interpreting results to provide actionable insights for clinical decision-making.
• Prepare and present statistical findings to internal stakeholders, including senior management and regulatory authorities, ensuring that results are communicated clearly and effectively.
• Develop and implement best practices for statistical programming and data management, enhancing the efficiency and accuracy of data analyses.
• Stay current with industry trends and advancements in biostatistics, integrating new methodologies and technologies into the team's practices.
• Collaborate with external partners, including contract research organizations (CROs), to ensure the successful execution of statistical analyses and reporting.
• Contribute to the preparation of publications and presentations for scientific conferences, showcasing the innovative work being done at Structuretx.
• Ensure compliance with Good Clinical Practice (GCP) and other regulatory requirements throughout all statistical activities.
• Participate in cross-functional project teams, providing statistical expertise to support strategic decision-making and project planning.

Requirements

• A Master's or Ph.D. degree in Biostatistics, Statistics, or a related field.
• At least 5 years of experience in biostatistics within the biopharmaceutical industry, with a proven track record of leading statistical analyses for clinical trials.
• Strong knowledge of statistical methodologies and regulatory guidelines, including ICH and FDA standards.
• Proficiency in statistical software such as SAS, R, or similar programming languages.
• Excellent communication skills, with the ability to convey complex statistical concepts to non-statistical audiences.
• Demonstrated leadership experience, with the ability to motivate and guide a team towards achieving common goals.
• Strong problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment.
• Experience with clinical trial design and analysis, including proficiency in survival analysis, longitudinal data analysis, and adaptive trial designs.
• Familiarity with data management processes and tools, ensuring data integrity and quality throughout the analysis process.

Nice to have

• Experience in oncology or rare disease therapeutic areas, which would be beneficial given Structuretx's focus.
• Knowledge of machine learning techniques and their application in biostatistics.
• Previous experience working with regulatory agencies during the submission process.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Advanced programming skills in Python or other statistical software.

Skills & tools

• Proficient in statistical analysis software (SAS, R)
• Strong understanding of clinical trial methodologies
• Excellent written and verbal communication skills
• Leadership and team management capabilities
• Problem-solving and critical thinking skills
• Familiarity with regulatory compliance and GCP

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel for meetings and conferences.
• The company offers competitive benefits, including health insurance, retirement plans, and opportunities for professional development.
• Structuretx is committed to fostering an inclusive workplace and encourages applications from diverse backgrounds.
• Interested candidates should apply through the provided URL to submit their application and resume.

Join Structuretx and be part of a team that is dedicated to making a meaningful impact in the lives of patients through innovative biopharmaceutical solutions. Your expertise in biostatistics will be crucial in shaping the future of our clinical development programs.

About the company

Medicine is our platform. Accessibility is our cure.