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 UK. We discover and develop 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 the input for clinical development plans. Identifies and assists in the implementation of innovative statistical approaches. Represents Statistics & Decision Sciences (SDS) cross-functional and intra-departmental teams and working groups.
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 partners such as the project team, the clinical trial team, and the Statistics Area Head. Follows standard methodologies for Data Integrity.
Drug Development: Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution. As a leader 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 for 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.
Disease Area Knowledge: Demonstrates knowledge across several disease areas/targets, including Renal and Gene Thereapy.
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 ways to statistical methods or business processes.
Mentoring: 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.
Processing: Leads process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.
Collaboration: Building and managing 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 problem solve. Collaborates within SDS to ensure integrated delivery across all phases of drug development.
Do you have the experience, skills and education we are looking for?
- PhD. in Statistics or related field 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.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)