Associate Director, Biostatistics

Job Summary Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. Job Description Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. Support statistical needs for market access and publications. Core team of developing final study report (FSR), including aut