Associate Director, Biostatistics (Remote, US) - Mitsubishi Tanabe Pharma

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 Associate Director, Biostatistics is responsible for providing statistical support to clinical development projects within designated therapeutic areas at MTPA. The incumbent also provides leadership to internal and/or consultant biostatistical staff.

Responsibilities

• Provides statistical support for assigned therapeutic areas with multiple projects throughout the complete product lifecycle, from clinical program design to product market and publication.
• Contributes to the design, conduct, analysis, and interpretation of clinical studies and research projects.
• Performs as project statistician for assigned therapeutic areas/products.
• Provides sample size estimates and power calculations for complex study designs.
• Reviews protocols and case report forms for soundness and quality of trial design.
• Jointly develops statistical methodology sections of protocol.
• Performs inferential (predictive) analysis.
• Participates in evaluating the relevant parts of bid proposals from external service providers, as well as contractual and service agreements.
• Oversees CRO deliverables for contracted statistical services.
• Provides statistical components of regulatory submissions.
• Assists the Department Head in the preparation of documents for submission to regulatory authorities including, but not limited to: Investigational Drug Applications (IND), New Drug Applications (NDA), Annual Reports, and other reports as required.
• Evaluates the objectives, performance, career and training needs of his/her biostatistics associates in cooperation with the Department Head.
• Participates in process and technical improvement initiatives.
• Participates in review and updating of established statistical SOPs and working practices.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Performs other departmental duties as assigned.

Qualifications

• Minimum M.S. in statistics, biostatistics or equivalent in a closely related field required
• Minimum of 6 (if Ph.D.) or 8 (if M.S.) years biostatistics experience in the pharmaceutical industry
• Experience with NDA/MAA submissions
• Experience as a sponsor representative at FDA/EMEA meetings
• Excellent statistical knowledge and project planning skills
• Knowledge of clinical trial research and regulatory requirements
• Familiarity with SDTM/AdaM CDISC guidance for submissions
• Knowledge of eCTD
• Strong interpersonal and communication skills and ability to collaborate effectively with other groups in a matrix organization

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 - $210,000. 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.