Janssen Scientific Affairs, LLS is hiring an Associate Director, Biostatistics to support the pulmonary hypertension (PH) Therapeutic Area and to be located in South San Francisco, CA.
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The Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence for post-approval studies and real world data (RWD) in the PH therapeutic area. You will take a leadership role in providing input to develop and implement real world evidence (RWE) strategies, RWE study protocols, statistical deliverables, and RWE Biostatistics Department's standardizations. Identifies and assists in the implementation of innovative statistical approaches.
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 programs. Is effective in the use of relevant computational tools for study, experiment, interdisciplinary approach and applications for RWD and RWE, and research objectives. Applies advanced statistical methodology in assigned projects and knowledge of health authority requirements.
Quality and Compliance: 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 under medical affairs.
Innovation: Seen as a leader in an area of technical expertise. Has a track record for suggesting, evaluating and implementing successful alternative or innovative approaches to statistical methods or business processes.
Representation: Represents statistical function in real-world evidence (RWE) activities and clinical trials under PH therapeutic area.
External Engagement: Actively participates as a member of professional organizations and works with PH KOLs to develop new therapies or treatment strategies on PH disease area. Peer reviews or edits professional journal manuscripts.
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 manages cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, KOLs, researchers, investigators) to achieve results for project specific needs with focus on improving communication, efficiency, and productivity.
Communication: Demonstrates excellent written, oral, and interpersonal communication skills.
Demonstrates ability to collaborate and consult with non-statisticians, translating statistical concepts. 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.
Ph.D. in Statistics or related field with minimum 8 years relevant experience, or Master's in Statistics or related field with minimum 10 years of relevant experience.
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 pulmonary hypertension.
Experience working in medical affairs.
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-California-South San Francisco-
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