At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson& Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
To fulfil our mission we are hiring an Associate Director, Statistics and Decision Sciences, to be located in the UK. In this highly transparent role, leading the quantitative aspects of the design, analysis and reporting of clinical trials at programme level ensuring that data generation, Interpretation and decision making are underpinned by fit-for-purpose statistical methods.
To be successful, you will be passionate about assessing the strength of evidence in clinical trial data, using established or innovative statistical methods to efficiently address the novel questions emerging in the dynamic landscape of oncology clinical research
The Statistics Associate Director:
- Understands the medical need in oncology target populations, partnering with colleagues to implement and assess statistical methods. Informing clear and efficient established or novel oncology study objectives and associated endpoints.
- Effectively Partnering with project teams (including medical and commercial leads, statistical programming, data management, medical writing, RWE, HTA, Biomarkers, Pharmacometrics, Bioinformatics) identifying appropriate clinical trial designs by proposing quantitative decision rules suitable to informing key study endpoints and their operational characteristics, by implementing flawless data analysis and reporting internally and for relevant publications.
- Demonstrates strong technical, analytical and interpersonal skills in project teams, internal forums and external meetings to establish and maintain methodologies constructively influencing decision making and clinical development strategy.
- Representing SDS in cross-functional and intra-departmental teams and in cross-industry working groups as appropriate.
- Serves as mentor or coach of junior SDS staff as appropriate.
Do you have the experience, skills and education we are looking for?
- PhD. in Statistics or related field or MSs in Statistics with track record of relevant problem-solving demonstrating advanced data analytic expertise based on a solid foundation of statistical principles and an ability to positively influence and support decision-making at program level and in regulatory interactions through effective communication.
- Proficient use of relevant computational tools for study, experiment, or trial research objectives (e.g. SAS, R, Python or similar) in individual workstations and in validated computer systems.
- Demonstrates knowledge of pharmaceutical research and development appropriate for providing SDS leadership and support to experimental design, modeling, analysis planning, analysis execution, interpretation and statistical communication in oncology.
- Is a leader in the optimization of study designs through scenario simulations and sample size calculations based on relevant assumptions in line with study or indication level objectives. Understands and aligns choice of methods with relevant regulatory guidance.
- Has a track record for proposing, implementing, evaluating and successfully communicating complex innovative statistical ideas and methods leading to improved business practices.
- Follows organization and company standard operating procedures as appropriate, including training and project time accounting and standard methodologies ensuring data integrity.
- Takes responsibility for and welcomes constructive feedback on the quality and timeliness of the assigned project deliverables, as assessed by partners such as the project team, the clinical trial team, and the Statistics Area Head.
- Serves as a role model to statisticians and other scientists as appropriate. Shares knowledge within and across functions to ensure integrated delivery across all phases of drug development. Supervises contractors or staff as required on a project basis. Mentors junior colleagues in techniques, processes, and responsibilities. Provides input into hiring decisions and ongoing evaluation of talent.
- Actively pursues robust cross-functional partnerships with internal colleagues and with external partners (e.g. Contract Research Organizations, consultants, researchers, investigators) to achieve results for project specific needs with focus on effective communication, efficiency, and productivity. Works cross-functionally to identify and problem solve when appropriate.
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 based on disability.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)