Director, Biostatistics

Overview:

Entrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA (edaravone) injectables in 2017 and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

The Director, Biostatistics is a leadership role responsible for managing biostatistics activities, and for the development and ongoing operation of the company's tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning and other algorithms to support clinical development activities.

Responsibilities:

• Responsible for statistical planning and execution of multiple clinical trials.
• Provide expertise to clinical trial design, SAP, and all trial-related documents, with need for Biostatistics expertise.
• Support the development and execution of biostatistics, statistical programming, and data management strategies to support clinical development activities.
• Provide statistical leadership into ongoing clinical trial programs and development of new programs.
• Ensure quality and timeliness of statistical, programming, and data management deliverables.
• Support interactions with global health authorities and partner contract research organizations as needed.
• Accountable for accuracy of statistical analyses and proposals in materials for health authority meetings.
• Provide resources and support analytical activities for scientific publications.
• Collaborate closely with members of the Statistical Programming, Data Management, and Medical Writing organizations.
• Establish and ensure adherence to biostatistics and statistical programming best practices, SOPs, standards, and processes.
• Collaborate with and oversee work of external service providers or suppliers involved in the drug development process.

Qualifications:

• Master’s degree in Biostatistics/Statistics required.
• Doctoral degree in Biostatistics/Statistics preferred.
• 10+ years in biotech/pharmaceutical industry in roles of increasing biostatistics responsibilities.
• Experience with multiple (s)NDAs, BLAs, MAAs required. J-NDA experience is a plus.
• Ideally has worked in multiple therapeutic areas and has experience with innovative Phase II clinical study designs for rare/uncommon disorders encompassing small molecules, large molecules, and biologics.
• Demonstrated record of fostering creativity, productivity, execution with urgency, teamwork, and accountability.
• Team-builder who leads by example and encourages collaboration across departments to achieve objectives.
• Comfort with model-based and agile drug development important. Appreciation for observational methodologies preferred.
• Ability to articulate complex methodologies to senior executives.
• Up to 20% domestic and international travel required.

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $160,000 - $235,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.