Associate Director, Translational Medicine & Early Development Statistics
Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for an Associate Director, Translational Medicine & Early Development Statistics (TMEDS) to be located in Raritan, NJ with consideration given to Titusville, NJ and Spring House, PA.
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 Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence Early/Late Development This position takes a leadership role in providing input to program plans. Identifies and assists in the implementation of innovative statistical approaches. Represents Statistics & Decision Sciences (SDS) cross-functional and intra-departmental teams or working groups, including Janssen senior management-level reviews. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.
Position Responsibilities:
Expertise: Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a consistent track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies advanced statistical methodology in assigned projects, such as clinical trials, with demonstrated integrated disease/scientific/functional area understanding and health authority acceptability.
Quality and Compliance: Follows organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Takes responsibility for the quality and timeliness of project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head. Follows standard methodologies for Data Integrity.
Drug Development: Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Is an established leader for providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation and statistical communications. Is accountable as a point of contact leader for a specific project or program and the management of all related project/program deliverables.
Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
Innovation: Seen as a recognized leader in an area of technical expertise. Has a track record for suggesting, evaluating and implementing successful alternative or innovative ways to statistical methods or business processes.
Representation: Represents Statistics & Decision Sciences on cross-functional and inter-departmental teams or working groups, including Janssen R&D senior management-level reviews. Able to serve as SDS representative for Due Diligence activities.
External Engagement: Actively participates as a member of professional organizations, such as attending meetings sponsored by professional organizations, serving professional organizations as an officer, event co-coordinator, or session chair; works with cross pharma consortium to develop industry standards. Peer reviews or edits professional journal manuscripts.
Mentor: Supervises contractors/special assignment personnel/interns/co-ops as required. Serves as a role model, and mentor to statisticians and other scientists. Shares knowledge within and across functions. Mentors junior colleagues in techniques, processes, and responsibilities.
Process: Leads process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.
Complexity: Successfully works on complex programs in terms of Scientific, Statistical, Health Authority, Operational, and/or Partnership issues. Identifies and implements advanced statistical approaches to handle complex project/program related features.
Collaboration: Builds and leads cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants, researchers/investigators) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity. Often serves an SDS point person for those partnerships. Works cross-functionally to identify and resolve issues. Collaborates within SDS to ensure integrated delivery across all phases of drug development.
Communication: Demonstrates excellent written, oral, and interpersonal communication skills. Demonstrates ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners. Bridges scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
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 Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence Early/Late Development This position takes a leadership role in providing input to program plans. Identifies and assists in the implementation of innovative statistical approaches. Represents Statistics & Decision Sciences (SDS) cross-functional and intra-departmental teams or working groups, including Janssen senior management-level reviews. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.
Position Responsibilities:
Expertise: Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level. Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a consistent track record of applied experience leading to successful support of multiple programs. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies advanced statistical methodology in assigned projects, such as clinical trials, with demonstrated integrated disease/scientific/functional area understanding and health authority acceptability.
Quality and Compliance: Follows organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Takes responsibility for the quality and timeliness of project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head. Follows standard methodologies for Data Integrity.
Drug Development: Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. Is an established leader for providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation and statistical communications. Is accountable as a point of contact leader for a specific project or program and the management of all related project/program deliverables.
Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
Innovation: Seen as a recognized leader in an area of technical expertise. Has a track record for suggesting, evaluating and implementing successful alternative or innovative ways to statistical methods or business processes.
Representation: Represents Statistics & Decision Sciences on cross-functional and inter-departmental teams or working groups, including Janssen R&D senior management-level reviews. Able to serve as SDS representative for Due Diligence activities.
External Engagement: Actively participates as a member of professional organizations, such as attending meetings sponsored by professional organizations, serving professional organizations as an officer, event co-coordinator, or session chair; works with cross pharma consortium to develop industry standards. Peer reviews or edits professional journal manuscripts.
Mentor: Supervises contractors/special assignment personnel/interns/co-ops as required. Serves as a role model, and mentor to statisticians and other scientists. Shares knowledge within and across functions. Mentors junior colleagues in techniques, processes, and responsibilities.
Process: Leads process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.
Complexity: Successfully works on complex programs in terms of Scientific, Statistical, Health Authority, Operational, and/or Partnership issues. Identifies and implements advanced statistical approaches to handle complex project/program related features.
Collaboration: Builds and leads cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations (CROs), consultants, researchers/investigators) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity. Often serves an SDS point person for those partnerships. Works cross-functionally to identify and resolve issues. Collaborates within SDS to ensure integrated delivery across all phases of drug development.
Communication: Demonstrates excellent written, oral, and interpersonal communication skills. Demonstrates ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners. Bridges scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
• A Ph.D. in Statistics or related discipline with minimum six (6) years relevant experience, OR a Master’s in Statistics or related discipline with a minimum of eight (8) years of relevant experience.
• Proficiency in R programming is required, SAS preferred.
• Knowledge of a computing language such as Python, Java or C++ is required.
• Hands on experience with statistical modeling and simulation is required.
• The ability to work independently and willingness to work in interdisciplinary contexts outside statistics is required.
• This position may require up to 10% domestic and international travel.
• Proficiency in R programming is required, SAS preferred.
• Knowledge of a computing language such as Python, Java or C++ is required.
• Hands on experience with statistical modeling and simulation is required.
• The ability to work independently and willingness to work in interdisciplinary contexts outside statistics is required.
• This position may require up to 10% domestic and international travel.