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
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.
position reports to a Director or above, and is an individual contributor
position with no direct reports. Matrix supervision may occur up to 5
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.
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.
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.
knowledge across multiple disease areas/targets within or across Therapeutic
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.
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.
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.
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 improvement or standards development initiatives. Provides input into
hiring decisions and ongoing evaluation of talent.
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.
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.
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
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.
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
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
in SAS or R programming is required
written, oral, and interpersonal communication skills.
to work independently.
ability to work in interdisciplinary contexts outside statistics.
experience designing, connecting, and analyzing neuroscience trials is strongly
leadership experience is a plus
United States-New Jersey-RaritanOther Locations
North America-United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function