Scientific Director, Biostatistics

Key Skills

Apache Hadoop, C Programming, C++, Data science techniques, Java Programming, Machine learning techniques, MapReduce, Python Programming, PyTorch, R Programming, Scala Programming, SQL, TensorFlow

Job Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientific Director, Biostatistics within its oncology group to be located in Raritan, NJ, Spring House, PA or La Jolla, CA!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The successful candidate contributes to the strategic statistical direction at Janssen through expert-level guidance and input to oncology programs in both hematologic malignancies and solid tumors, for research, development, and/or marketed product needs in Janssen. Provides guidance and direction to other statisticians, and is a leader for strategies, structures, processes, skills, and culture within SDS and serves as a role model for living the Credo and demonstrating the J&J Leadership Imperatives for Leaders: Lead, Shape, Connect, and Deliver.

Core competencies, Responsibilities and Accountabilities:

• Provides collaborative leadership to other drug development scientists through consultation and mentoring.
• Oversees the delivery of analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs.
• Partner with other Quantitative Sciences (QS) functions, contributes to strategic long-term decision-making by Janssen Senior Management. 
• Participate in external activities to help shape the external drug research and development and regulatory environments. 
• Play a central role in sharing the knowledge and aligning the strategy across all Statistics & Decision Sciences (SDS) support (Early/Late Development, Medical Affairs, and Real World Evidence) for technical/scientific aspects of a particular Disease/Functional Area.
• Demonstrate the ability to influence drug research & development strategic plans formulated with Senior Management.
• Ensure consistent approaches across compounds and in alignment with regulatory guidance as appropriate. 
• Take an expert level lead in developing and applying strategic quantitative frameworks and scenario simulations to evaluate risk tolerance and options to optimize program and analysis strategies. 
• Bridge scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence. 
• Ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners and positively influencing decisions.
• Serves as a role model, and mentor to statisticians and other scientists. Takes a lead role in sharing statistical knowledge, within SDS and/or cross-functionally. Mentors’ junior colleagues in techniques, processes, and responsibilities.

Qualifications Required:

• Ph.D. in Statistics or related field with minimum 9 years relevant experience, or Master’s in Statistics or related field with a minimum of 11 years of relevant experience.
• Strong experience in regulatory activities (e.g. submissions, interactions) is required. 
• Have an advanced understanding of drug development processes and programs
• Ability to work in a matrix organization and cross-functionally to identify and resolve issues
• Proficiency in SAS or R, as well as a working knowledge of other relevant computational tools
• Highly effective written, oral, and interpersonal communication skills
• Demonstrated statistical knowledge and expertise across multiple disease areas/targets within or across Therapeutic Areas (TAs)

Preferred:

• PhD preferred.
• Oncology TA knowledge and expertise is preferred
• Previous leadership experience is preferred

This role will have up to 10% domestic and international travel.