Associate Director, Statistical Programming

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 the Associate Director, Statistical Programming, you will be responsible for managing various programming activities throughout all stages of clinical development.  You will provide programming expertise to the study and project teams, while leading, managing and developing programmers.  

This position reports to the Director of Statistical Programming and can be based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and remote options will be considered for US candidates. 
  
Job Description 

• Function as technical lead and project manager for studies and projects by managing all aspects of study deliverables related to Statistical Programming including validation plans. 

• Collaborate with cross-functional groups such as Biostatistics, DM and Clinical Management. 

• Manages project timelines for studies and projects and collaborates with study teams and vendors to ensure quality, on time deliverables.

• Represent Statistical Programming in providing solutions to technical problems. 

• Adopt and adhere to standards, processes, validation and programming plans, and modern technology within the Statistical Programming group and D&A organization. 

• Work with the Statistical Programming leadership team to implement Statistical Programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency. 

• Coach, mentor and develop direct reports. 

• Participate in Programming and company initiatives. 

• Drive and manage training compliance for resources under direct management.  

• Participate in recruiting and hiring process for qualified candidates. Provide input for the selection of vendors and perform appropriate oversight of the selected vendor. 

• Travel (approximately 15%)   

 
Qualifications/ Required 
Knowledge/ Experience and Skills: 

• Experience in developing statistical base programming and database management. 

• Excellent knowledge of SAS programming. 

• Strong knowledge of relational database structures. 

• Excellent knowledge of regulatory requirements. 

• Understanding of the company's products, the competition, and the pharmaceutical industry. 

• Excellent written and verbal communication skills, with the ability to convey complex information to both technical and non-technical audiences. 

• Demonstrated abil