Associate Director, Statistical Programming (Remote, US)

$150,000 - $200,000/Yr

Mitsubishi Tanabe Pharma - Jersey City, NJ

Full-time - Senior

Remote - Jersey City, NJ

Chemical Manufacturing

About the position

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, Statistical Programming is responsible for building and maintaining a statistical programming infrastructure to ensure timely, high quality programming support to clinical development projects within designated therapeutic areas at MTPA. The incumbent also provides leadership to internal and/or consultant statistical programming staff.

Responsibilities

• Provide clinical programming support for a variety of clinical development activities including, but not limited to, creating outputs for: clinical study report, interim analyses, data safety monitoring committees, manuscripts, conferences, ad hoc analyses, and exploratory analyses.
• Support the implementation of global programming standards and conventions.
• Develop and/or oversee the development of SAS programs that create macros, catalogs, analysis datasets, tables, listings, and figures.
• Provide input to other clinical development deliverables including statistical analysis plans, data management plans, electronic data entry screens, and CRFs.
• Prepare validation and QC tracking sheets.
• Anticipate or identify programming infrastructure needs including hardware, software, methodologies, and staffing, and suggests preemptive or timely proposals for remediation.
• Assist the Department Head with programming requirements 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, Safety Summaries and other reports, as required.
• Maintain programming infrastructure which optimizes the physical and technical security of MTPA data.
• Evaluate the objectives, performance, career and training needs of his/her Programming associates in cooperation with the Department Head.
• Participate in process and technical improvement initiatives.
• Participate in review and updating of established programming SOPs and working practices.
• Perform other departmental duties as assigned.

Requirements

• M.S. in statistics/biostatistics, computer science or equivalent in a closely related field is preferred
• Minimum of 8 years clinical SAS programming experience in the pharmaceutical industry
• Experience with NDA/MAA submissions
• Experience with SDTM/AdaM CDISC guidance for submissions
• Experience with eCTD
• Excellent statistical programming skills
• Knowledge of clinical trial research and regulatory requirements
• Strong interpersonal and communication skills and ability to collaborate effectively with other groups in a matrix organization

Benefits

• Medical and Dental health benefits
• Short-term and long-term disability plans
• Company Paid and Supplemental Life insurance
• Critical Illness Insurance
• Accident Insurance
• Legal Plan
• ID Theft Protection
• Generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date