Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Statistician/Principal Statistician/Associate Director within Pulmonary Arterial Hypertension (PAH) biostatistics department. The individual is to be located primarily in Allschwil, Switzerland (Actelion (J&J)).
He/She provides lead support or significant contribution for the design, execution, analysis, interpretation, and reporting or communication of clinical trials and related activities for research, development, and/or marketed product needs in Actelion (Janssen). This position takes a leadership role in providing input to program plans, identifies and assists in the implementation of innovative statistical approaches. This position represents Actelion Biostatistics and Janssen Statistics & Decision Sciences (SDS) cross-functional and intra-departmental teams or working groups, including Actelion and Janssen senior management-level reviews.
Core competencies, Responsibilities and Accountabilities:
- Provide statistical expertise at all stages of the design and implementation of clinical studies from planning and design through to completion, in close collaboration with multi-disciplinary research teams:
- Provide input into the concept, design and development of study protocols to ensure appropriate and scientifically sound methods on study design and analysis are being used;
- Develop statistical analysis plans, perform and/or guide analyses;
- Provide statistical insight in the interpretation and discussion of study results, and supply to the study reports (interim, final);
- Support to study reports and publications;
- Handle and are responsible for the statistical CROs and external organizations;
- Plan for, deliver and be accountable for all statistical outputs and their quality
- Contribute to the regulatory submission activities: planning, strategy, documents and analyses
- Handle all statistical activities within the project and liaise with the quantitative science partners.
- Communicate and explain complex statistical methods, analysis results through internal/external presentations and publications to different partners.
- Follow organization and company standard operating procedures in timely fashion, such as training and project time accounting.
- PhD or Master's degree in Statistics with minimum of 6 years of relevant experience in Pharmaceutical companies or CRO.
- Experience in Pulmonary Arterial Hypertension and Rare Disease is preferred.
- Proficiency in SAS or R, as well as a working knowledge of other relevant computational tools is requre4d.
- Analytical creative mind, passionate about translating complex statistical concepts to drug research & development, market-access of global medical affairs partners; intellectual curiosity, eager for continuous learning.
- Ability to work independently as well as to collaborate in a multidisciplinary regional team and to run multiple projects under tight deadlines.
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)