Sr Principal Scientist Biostatistics

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Position Summary

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.

Position Core Competencies Responsibilities and Accountabilities (including lower pay grade level requirements not explicitly re-stated here)

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: Complies with organization and company standard operating procedures in a

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 (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 (Therapeutic

Area (TA)) team led by the Global Statistical Sciences TA Head.

Disease Area Knowledge: Demonstrates knowledge across multiple disease areas/targets within or

across Therapeutic Areas (TAs).

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

Position Core Competencies Responsibilities and Accountabilities (including lower pay grade level requirements not explicitly re-stated here)

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 an 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.

Area Specific Core Competencies Responsibilities and Accountabilities

These are additional to the above position core competencies applicable to individuals according to their

assigned area within Statistics & Decision Sciences.

Discovery & Translational

Provides experimental design analysis interpretation and statistical communications support.

Ensures application of appropriate statistical methods and generation of accurate and

reproducible results.

Produces clear concise well-organized and error-free computer programs and statistical

reporting content.

Documents projects in sufficient detail for reproducibility.

Serves as initial consultation contact for new projects. Maintains and grows customer base and

builds loyal relationships with customers.

Assumes independent professional responsibility for all phases of a project request from

beginning through completion.

Manages multiple projects.

Leads Statistical Input for at least one functional area research field or compound.

Provides input to product development and performs statistical functions for submission

related activities where appropriate.

Regularly presents at external conferences and meetings and advisory boards when

necessary.

Partners with other statisticians in developing publications (e.g. manuscripts oral

presentations posters abstracts and internal technical reports) and creating software.

Develops methodologies for the use of emerging technologies.

Contributes to the advancement of statistical methodology through publications.

Contributes to the advancement of software though software development.

Represents the company by making presentations to industry conferences and associations.

Identifies and collaborates with experts and external partners to achieve results for project specific needs.

Required Skills:

Preferred Skills: