Associate Director, Biostatistics

Job Title: Associate Director, Biostatistics

Location: Remote or Hybrid, with 2-3 days in the office if within commuting distance of Menlo Park, CA or Waltham, MA

Role Overview:

The Associate Director of Biostatistics will provide statistical leadership and operational execution for clinical development programs and individual clinical trials. This individual will serve as the lead biostatistician for multiple Phase I to IV clinical studies and will be responsible for providing expert guidance on study design, statistical analysis plans, and the reporting and interpretation of clinical trial results. The ideal candidate will bring a strong foundation in statistical methodology, curiosity for staying informed on advances in statistics, proficiency in statistical programming languages, independence in managing project deliverables, and the ability to work collaboratively across different functions in a fast-paced biotech environment.

Key Responsibilities:

• Drive statistical execution for assigned programs, providing critical input on study design, protocol development, and statistical analysis planning while collaborating closely with cross-functional study teams.
• Manage and track biostatistics timeline and deliverables for assigned projects, ensuring timeline completion of quality deliverables while proactively communicating resource constraints and risk.
• Authors and critically reviews protocol statistical sections, statistical analysis plans, clinical study reports, associated publications, and other study level documents with a high degree of independence.
• Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure alignment with protocol objectives and statistical analyses.
• Develop statistical programs to support ad-hoc analysis requests, manuscripts and presentations. Provide critical statistical review of scientific reports and publications, ensuring appropriate and accurate data presentation.
• Oversee CRO biostatistics vendors, including timeline and deliverable management while ensuring quality deliverables within agreed timelines..
• Ensure compliance with company SOPs and working practices, ICH and GCP guidelines, and regulatory standards.

Qualifications:

• Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of experience in clinical trials, or a Masters degree with 8+ years of experience.
• Strong, up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, sample size determination, statistical modeling and analysis.
• Proven capability to provide statistical leadership and guidance to cross-functional teams at the study and project level and exercise independent judgement.
• Familiarity in the design, data capture, and analysis of clinical trials with potentially high placebo response.
• Experience in the area of Immunology and Inflammation is highly desirable.
• Knowledge of applicable FDA/EMA regulations, ICH-GCP guidelines, and statistical submission requirements. Expertise in CDISC standards, including ADaM requirements
• Advanced proficiency of the SAS programming language; knowledge of R or similar language a plus.
• Strong organizational and time management skills, with a demonstrated ability to prioritize multiple concurrent deliverables and ad-hoc requests.
• Excellent communication, leadership, and analytical skills.
• Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, $182,000 to $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.