Job Title: Director of 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 Director of Biostatistics will provide statistical leadership and strategic direction for our clinical development programs. 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 interpretation of clinical trial results as well as statistical support for regulatory submission activities. The candidate will represent the Biostatistics function at internal and external meetings. 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:- Lead statistical strategy for Oruka's clinical development programs, including study design, protocol development, and statistical analysis planning, while collaborating closely with cross-functional study teams.
- Plan and track biostatistics timeline, deliverables and resources for assigned projects, ensuring timeline completion of quality deliverables while proactively communicating resource needs, constraints and risks.
- Independently authors and/or reviews protocol, statistical analysis plans, clinical study reports, associated publications, and other study level documents.
- 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.
- Write the statistical sections of regulatory documents and collaborate with Clinical and Regulatory to support Oruka's regulatory strategy.
- Participate in the assessment, selection, and oversight of CROs within area of responsibility.
- 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 7+ years of experience in clinical trials, or a Masters degree with 10+ years of experience.
- Strong, up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis.
- Proven capability to provide statistical leadership to cross-functional teams at the study and project level, exercise independent judgement and provide oversight to junior statisticians
- 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, $213,000 to $240,000. 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.
Salary Range for the Role
$213,000-$240,000 USD
What We Offer:- A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
- Competitive salary and benefits package.
- A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
- Opportunities for professional growth and development.
