Principal, Biostatistician

Denali Therapeutics; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics seeks an experienced biostatistician to shape the statistical strategy across the clinical development lifecycle, from first-in-human to pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.

The role requires a Ph.D. in Statistics/Biostatistics (or equivalent with 6+ years) and strong R/Markdown/Quarto skills, plus CDISC SDTM/ADaM knowledge. You will mentor biostatisticians, lead cross-functional teams, and influence regulators and vendors.

Qualifications

• Ph.D. in Statistics, Biostatistics, or related field with 6+ years of experience in study level strategy and decision making.
• Late-stage (Phase 3) clinical trial planning, conduct, and reporting experience.
• Strong programming in R and Markdown/Quarto; working knowledge of git and Unix/Linux environments.

Responsibilities

• Design and lead statistical strategy across the full clinical development lifecycle, from first-in-human through pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
• Lead development of key clinical study deliverables, including statistical analysis plans, protocol statistical sections, and clinical study reports.
• Exercise independent judgment in selecting and adapting statistical methods where standard approaches don't fully apply.
• Own the statistical integrity and accuracy of analysis and reporting deliverables against SOPs and regulatory requirements.
• Lead exploratory analyses, sample size estimation, and modeling/simulation to generate insight from ambiguous or incomplete data.
• Present statistical strategy and findings to senior management and influence cross-functional decision-making.
• Oversee and mentor other biostatisticians, providing technical direction without formal people-management authority.
• Manage and provide oversight of Biostatistics vendors and CROs, including performance and quality of external statistical deliverables.
• Maintain expert knowledge of statistical methodology, therapeutic-area drug development, and the evolving regulatory environment.

Skills

Statistical strategy

Mentoring

Regulatory interactions

Education

PhD in Statistics/Biostatistics

Master's degree with equivalent experience

Tools

R

Markdown/Quarto

Git

Unix/Linux

CDISC SDTM ADaM

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.This role shapes the statistical strategy that carries Denali's clinical programs from first-in-human studies through pivotal registration trials. It applies deep scientific judgment to problems with significant ambiguity, working with intangible variables that affect development timelines and regulatory outcomes. The role builds Denali's emerging reputation in biostatistics by driving intangible-variable analysis, mentoring statistical staff, and representing the function in interactions with regulators, vendors, and cross-functional leadership.Key Accountabilities / Core Job Responsibilities:Design and lead statistical strategy across the full clinical development lifecycle, from first-in-human through pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.Leads development of key clinical study deliverables, including statistical analysis plans, protocol statistical sections, and clinical study reports.Exercise independent judgment in selecting and adapting statistical methods where standard approaches don't fully apply.Own the statistical integrity and accuracy of analysis and reporting deliverables against SOPs and regulatory requirements.Lead exploratory analyses, sample size estimation, and modeling/simulation to generate insight from ambiguous or incomplete data.Present statistical strategy and findings to senior management and influence cross-functional decision-making.Oversee and mentor other biostatisticians, providing technical direction without formal people-management authority.Manage and provide oversight of Biostatistics vendors and CROs, including performance and quality of external statistical deliverables.Maintain expert knowledge of statistical methodology, therapeutic-area drug development, and the evolving regulatory environment.Qualifications/Skills:Typically requires a Ph.D. in Statistics, Biostatistics, or a related discipline with 6+ years of relevant experience including responsibility for study level strategy and decision making or a Master's degree in a related discipline with equivalent related experience.Typically requires late-stage (Phase 3) clinical trial planning, conduct, and reporting experience.Strong programming proficiency in R and Markdown/Quarto; working knowledge of git and Unix/Linux environments.Working knowledge of CDISC, SDTM, and ADaM data standards.Demonstrated ability to lead cross-functional teams and influence senior stakeholders without direct authority.Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careersThis compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.