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 maintaining everyday health.

As The Director, Statistical Programming, you will be a champion of Otsuka’s culture and values and serve in a leadership role within the Statistical Programming group.   You will be an experienced leader managing the statistical programming activities for clinical studies and projects within the assigned therapeutic area(s) to ensure quality and deliverables and will support the vision and strategy of the Statistical Programming group and the Data and Analytics (D&A) organization.

You will report to the Head of Statistical Programming.

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.

Job Description:

• Guide Statistical Programming activities within the therapeutic area(s) and to develop the strategy for quality and deliverables.

• Drive the adoption and adherence of standards, processes, validation and programming plans, and new technology within the Statistical Programming group and D&A organization.

• Serve as the in-house expert and key advisor to head of the Statistical Programming group on the programming strategy by providing assessment of state-of-art and industry trends in ways of working, efficient coding such as macro library and utility macros, and technology.

• Maintain forward-looking resource forecasts to allocate efficient use of resources to their projects.

• Collaborate with cross-functional teams, including Clinical Management, Clinical Development, Pharmacovigilance, Biostatistics, Data Management, Medical Writing, Asset Management and IT, to ensure agreement on analysis and reporting deliverables for clinical trials and projects.

• Work with IT business partners to build and maintain secure statistical computing environment and infrastructure as per the 21 CFR part 11.

• Collaborate with the other Statistical Programming leaders and the D&A Leadership Team to identify areas of improvement and clarity on strategic plans for processes, standards, systems, resourcing, and other initiatives.

• Engage in stakeholder management within D&A organization and across the Otsuka organization.

• Responsible for people management which includes coaching, mentoring, and developing direct reports.

• Manage training compliance for resources under direct management.

• Participate in hiring process for qualified candidates.

• Provide input for the selection of vendors and perform appropriate oversight of the selected vendor.

Minimum Qualifications:

• Knowledge of SAS programming, and strong knowledge of relational database structures and data workflow.

• Excellent knowledge of regulatory requirements as they relate to statistical programming and validation.

• Master’s degree or equivalent + 15 years of related work experience.

• 8-10+ years in Data Standards and Statistical Programming.

• 8-10+ years in Life Sciences with demonstrated knowledge of drug development process.

• Strong understanding of data management principles and technologies, data integration, and data quality assurance.

• Strong knowledge of submission to global regulatory health authorities.

• Experience with leading and implementing data governance initiatives, policies, and procedures.

• Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology.

• Excellent project management skills with the ability to prioritize and manage multiple projects simultaneously.

• Strong leadership and interpersonal skills with the ability to collaborate with cross-functional teams and stakeholders at all levels.

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

• Demonstrated ability to stay updated with industry trends, emerging technologies, and regulatory changes.

• Experience leading, collaborating with and influencing matrix teams.

Preferred Knowledge, Skills, and Abilities:

• 8 -10+ years of management experience

Our Benefits:

• Comprehensive medical, dental, vision and p