Rakuten Aspyrian, Inc., is a privately funded, clinical stage Biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Aspyrian has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Aspyrian plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.
Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.
Rakuten Aspyrian is currently sponsoring a global Phase 3 multicenter clinical study to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy in patients with other cancer types.
Given the rapid progression of the clinical studies, we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.
Key Duties and Responsibilities
- Continue to build the current team (biostatistician, statistical programmers and data management) and lead the team to support early phase, late phase, and post marketing product development programs with accurate statistical science data.
- The team members must be able to deliver statistical and analytical direction and recommendations to support product development allowing the execution of multiple development programs, company strategies, and goals.
- Continue developing, implementing statistical analysis processes, policies, and statistical analysis plans that support company programs including global filings and commercialization.
- Key member of the Global Portfolio Team providing statistical insight and guidance
- Maintain strategies, projects and goals that assure data have statistical integrity, adequacy and accuracy.
- Able to create a team that is able to be a strong strategic partner to all company cross functional teams providing excellent statistical data analysis. This will include life cycle teams and translational research teams.
- Participating in the ongoing development, refinement and enhancements of departmental SOPs, methodologies and techniques for biostatistics research, analysis and reporting
- Able to represent function at regulatory meetings, inspections/audits, and Company partnerships internal and external.
- Identify study-level vendor requirements and participate in the evaluation, selection and management of analytical vendors
- Maintain informed of the area of expertise as it relates to products and programs.
- Support from the function’s perspective for all products, health economics, outcomes research projects, due diligence, regulatory responses, congresses, and publications.
- Assuming statistical responsibility for major segments of each project which may include authoring protocol statistical analysis sections and statistical analysis plans and manage study randomization code.
- Able to demonstrate and help maintain the company’s values, mission, and culture to assist in creating a great place to work.
- Able to create and lead a cohesive and collaborative team and resource the unit appropriately.
- Able to create and manage team budget to remain aligned with company budget.
- Works effectively and collaboratively with colleague toward achieving corporate goals.
- Strong ability to influence and listen which leads to an efficient team.
- Leads independently in areas of high experience and expertise.
- Strong organizational skills, able to analyze large data quickly, detail oriented and adapts in a dynamic, and fast paced global environment.
- Leads self and team in a positive and respectful manner.
- Demonstrate ownership of deliverables, takes initiative and hold self and others accountability.
- Enjoys mentoring and coaching when warranted (direct reports and peers).
- Ability to interact as an effective function leader who is a team player encouraging collaboration in a multifunctional and multidisciplinary team setting.
- Good communication skills, written, verbal, and presenting with credibility and confidence.
- A strategic thinker that is able to evaluate and analysis data that facilitates to a scientific decisions or recommendations.
- Seeks feedback to continuously grow.
- Able to appropriately escalate and deescalate concerns with stakeholders.
- Other duties as assigned (always end the essential functions section with this bullet)
Desired Education, Skills and Experience
- PhD + 7 years’ experience or Masters Degree + 10 years’ experience in statistics/biostatistics (PhD is preferred).
- Sound knowledge of ICH-GCP and other relevant standards and guidelines.
- Must demonstrate sound knowledge and experience in all phases of drug development knowledge of oncology, preferred at least 6 years experience on product development or life cycle teams.
- Proven experience in the principles and techniques of data analysis, interpretation and clinical relevance.
- Experience in creative clinical trial statistical designs.
- Proven experience in interactions with regulatory authorities including NDA/BLA submission experience to FDA and EMA, also PMDA preferred; experience leading discussions with regulatory authorities and health authorities.
- Experience managing CROs and external partners to ensure high quality, on time and on budget statistical outputs.
- Proven track record of meeting or exceeding objectives and goals.
- Strong analytical and problem-solving capabilities and skills.
- Experience and valued member of cross-functional product development teams and life cycle teams.
- Good knowledge of ICH Guidelines, FDA safety regulations, or EMA regulations.
- Experience in management of direct or indirect reports.
- Willingness and ability to travel domestically or internationally as required.
Location: San Mateo, CA