Associate Director, Biostatistics

The Opportunity

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

Denali Therapeutics is seeking to recruit a highly experienced associate director. The candidate will lead Biostatistics planning activities and deliverables in support of Denali's core clinical development programs, and use a combination of curiosity and statistical acumen to identify and solve interesting problems. This position will report to the Senior Director of Biostatistics.

Responsibilities

Devise and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions. Accountable for accuracy and statistical integrity of analysis and reporting deliverables ensuring deliverables meet pre-specified analysis requirements, internal SOPs, and external regulatory requirements. Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation, and create tools to gain useful insights from data as needed. Interpret, summarize and present data and statistical considerations to internal project teams and Denali senior management. Collaborate with Clinical Operations to select, contract, and manage Biostatistics vendors and contract research organizations. Provide oversight on the activities of both in-house and external statistical service providers as appropriate. Lead department level strategic goals. Keep up to date on new developments in statistics, drug development in the relevant indication space, and the regulatory environment. Provide technical oversight and mentorship to direct reports and developing biostatisticians.

Requirements

• Ph.D. in Statistics or Biostatistics with 5+ years of pharmaceutical experience (or Master's degree in a related discipline with 10+ years of relevant experience).

• Substantive expertise in statistical methodology and its application to solve problems in the pharmaceuticals/biotechnology setting.

• Late stage clinical experience, Phase 3 planning, conduct, and reporting.

• Strong analytical and problem solving skills; expert collaboration and communication skills.

• Strong programming skills in R, Markdown/Quarto; working knowledge of git and unix/Linux environments.

• Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.

• Ability and interest to work cross functionally with basic science research and clinical colleagues.

• Highly independent, curious and creative, can do attitude, and embraces continuous improvement culture.

Salary Range: $192,000.00 - $232,667.00. 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/careers

This 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.

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