Associate Director, Statistics
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
2777170217/2-en-us

Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring an Associate Director, Statistics to be located in Raritan, NJ or Titusville NJ. Minimal travel is required.

  

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide.  Research and development areas encompass novel targets in cardiovascular diseases, metabolic disorders, neurologic disorders, gastroenterology, oncology, infectious diseases, hematology, immunologic disorders, and reproductive medicine.

 

Janssen Research & Development, L.L.C., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more information, visit www.janssenpharmaceuticalsinc.com


The Associate Director provides 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 innovative 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.


This position reports to a Director or above, and is an individual contributor position with no direct reports. Matrix supervision may occur up to 5 individuals.


The Associate Director will:

  • Have 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.
  • Comply 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.
  • Demonstrate 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.
  • Demonstrate knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
  • 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.
  • Represent 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. 
  • 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.
  • Supervise 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.
  • Lead process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.
  • Successfully work 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.
  • Build 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 a 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.
  • Demonstrate 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.
  • Provide critical statistical oversight to Medical Affairs clinical studies and assumes a leadership role in clinical trial and/or patient registries planning (mostly Phase 3b/4 trials or observational studies for post marketing commitments/requirements) and reporting related activities; assumes the role of a Statistics representative for cross-functional teams and works on several trials (projects) simultaneously. 
  • Provide statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support;  Contributes/leads clinical study design, analysis planning and  for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for MA studies; Provides input to product development and performs statistical functions for submission related activities; Provides statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities); May serve as a primary contact with outside investigators (and vendors)in the preparation of scientific presentations and manuscripts; may interact with external Key Opinion Leaders (KOLs) and pursues rigorous statistical analyses in support of business-critical new research ideas; Explores and implements innovative statistical methods; Represents department in meetings with regulatory agencies.


Qualifications
  • Ph.D. in Statistics or related field with minimum 6 years’ relevant experience, OR Master’s in Statistics or related field with a minimum of 8-10 years’ of relevant experience.
  • Proficient in SAS or R programming is required
  • Excellent written, oral, and interpersonal communication skills.
  • Ability to work independently.
  • Demonstrated ability to work in interdisciplinary contexts outside statistics.
  • Prior experience designing, connecting, and analyzing neuroscience trials is strongly preferred
  • Prior leadership experience is a plus 


Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Biostatistics
Requisition ID
2777170217

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