Associate Director, Biostatistics- Immunology Early Development
Job Description Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Biostatistics to support the early development of immunology compounds to be located in Spring House, PA. The Associate Director is responsible for providing statistical support and leadership to Early Development activities related to the planning, design, conduct, analysis, interpretation and reporting of data evidence of clinical trials. He/she represents statistical function in the clinical team, interact effectively with clinical and other functional leaders, provide guidance to team for unexpected difficulties, and ensure consistency and high-quality statistical deliverables. He/she also collaborates with colleagues and leadership in the Translational Medicine and Early Development Statistics and other Quantitative Sciences (QS) functions to identify and implement innovative statistical approaches to challenge issues and contribute to strategic long-term decision-making by Janssen Senior Management. The Associate Director also participates in external activities to help shape the external drug research and development and regulatory environments, and serves as a role model for living the J&J Credo and demonstrating the J&J Leadership Imperatives for individuals:
lead, shape, connect, and deliver. Principal Responsibilities and Expertise:
Has an established track record of problem-solving and troubleshooting including significant 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:
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. 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. 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 within or across therapeutic areas. 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. 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 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. Qualifications 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. Proficient in SAS or R programming is required. Demonstrated ability to work in interdisciplinary contexts outside statistics is required. Excellent written, oral, and interpersonal communication skills. Ability to work independently. 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, candidates offered employment must show proof of COVID-19 vaccination or 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.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
lead, shape, connect, and deliver. Principal Responsibilities and Expertise:
Has an established track record of problem-solving and troubleshooting including significant 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:
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. 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. 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 within or across therapeutic areas. 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. 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 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. Qualifications 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. Proficient in SAS or R programming is required. Demonstrated ability to work in interdisciplinary contexts outside statistics is required. Excellent written, oral, and interpersonal communication skills. Ability to work independently. 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, candidates offered employment must show proof of COVID-19 vaccination or 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.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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