Janssen Research & Development a member of the Johnson & Johnson Family of Companies is currently recruiting for an Associate Director, Clinical Biostatistics located in Raritan, NJ with consideration given to 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.
You will provide lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre/Early/Late Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen. This position takes a leadership role in providing input to program plans. Identifies and assists in the implementation of creative 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.
Core Competencies, Responsibilities and Accountabilities:
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 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.
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 stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Follows best practices 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 (e.g. CTSL, Indication Lead, Discovery Lead, Manufacturing Lead) 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.
Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
Communication: Demonstrates excellent 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 intelligence.
• A Ph.D. in Statistics or related field with minimum six (6) years relevant work experience OR a Master’s Degree in Statistics or related field and a minimum of eight (8) years of relevant work experience
• Deep understanding and knowledge of the drug development process
• Experience executing compound development strategies
• Proficient in SAS or R programming
• Excellent written, oral, and interpersonal communication skills.
• Ability to work independently
• Demonstrated ability to work in interdisciplinary contexts outside statistics
• Experience working in the Oncology TA
This position may require up to 10% domestic and international travel.
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-
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)