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Associate Director, Biostatistics
Company: Johnson & Johnson
Location: Raritan, NJ
Employment Type: Full Time
Date Posted: 05/07/2022
Expire Date: 11/09/2022
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Employment Placement Agencies, Finance/Economics, Healthcare, Practitioner and Technician, Human Resources, Information Technology, Science, Quality Control, Research & Development
Job Description
Associate Director, Biostatistics

Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Associate Director, Biostatistics to support the development of compounds for cardiovascular diseases within the Cardiovascular Therapeutic Area to be located in High Wycombe, England or Raritan, NJ.

 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

 

In this highly visible role, the Associate Director provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data. This position takes a leadership role in providing input to clinical development 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, as well as face-to-face health authority interactions. The Associate Director abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.

 

  • 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 collaborators 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 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.
  • Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets, including cardiovascular diseases.
  • 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 approaches 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 as evidenced by prior experience assessing in-licensing opportunities.
  • 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 consortiums 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 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 the 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 to fold quantitative strategic insights into development programs to enhance the probability of success – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence.
  • Programming: Demonstrates full proficiency in SAS and/or R, as well as a working knowledge of other relevant computational tools as required.

Qualifications
  • Ph.D. in Statistics or related field with minimum 5 years relevant experience.
  • Proficient in SAS and/or R programming.
  • Excellent written, oral, and interpersonal communication skills.
  • Ability to work independently.
  • Demonstrated ability to work in interdisciplinary contexts outside statistics.

 

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.

 

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.


Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2206034775W
Contact Information
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