Job Title: Director of Biostatistics

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

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 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, 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 input, and statistical analysis planning.
• Plan and track biostatistics timeline and resources for assigned projects, ensuring timeline completion of quality deliverables. Proactively communicate resource needs.
• Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.
• Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide 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, industry 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
• Up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis
• 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 a plus.
• Knowledge of applicable FDA regulations and ICH guidelines
• Expertise in CDISC standards, including ADaM requirements
• Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus.
• Strong organizational and time management skills, and the ability to prioritize multiple 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 is $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.