Associate Director, Clinical Biostatistics
- Raritan, NJ
Janssen Research & Development, L.L.C., a Johnson & Johnson company is recruiting an Associate Director, Clinical Biostatistics to be located in Raritan, NJ., Spring House, PA or Titusville, NJ.
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, Clinical Biostatistics provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence Early/Late Development in the Oncology Therapeutic Area. 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.
Other responsibilities include:
- 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 strong 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.
- Complies with 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 stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Follows best practices for Data Integrity.
- 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 communication.
- Is accountable as a point of contact leader for a specific project or program and the management of all related project/program deliverables. Is an established leader for providing input to team in terms of optimizing study or trial designs in line with study or indication level objectives and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional knowledge. May serve on the SDS TA team led by the Global Statistical Sciences TA Head.
- Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
- 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.
- 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.
- Leads process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.
- 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.
- Builds and manages 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 as 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.
- 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.
- Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
- Ph.D. in Statistics or related field with minimum 6 years relevant experience, or Master's in Statistics or related field with commensurate years of relevant experience required.
- Experience with at least one therapeutic area (preferably oncology) required.
- Proficient in SAS or R programming required.
- Excellent written, oral, and interpersonal communication skills required.
- Ability to work independently preferred.
- Demonstrated ability to work in interdisciplinary contexts outside statistics required.
- Ability to travel up to 10% preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
United States-New Jersey-Titusville, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
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