Actelion is a leader in the field of pulmonary hypertension (PH). Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
Location: Allschwil, Switzerland
The Associate Director of Biostatistics provides lead support 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. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Craft, Connect, and Deliver.
Macitentan High Dose in PAH
You will be responsible for the macitentan high dose project in pulmonary arterial hypertension. You will be leading all aspects of the design, initiation, conduct and reporting of the clinical trials. Also, you will be responsible for owning the interactions with the health authorities (FDA, EMA).
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;
You perform analyses sought at integrating multiple sources of evidence to inform study design;
Provide statistical insight in the interpretation and discussion of study results, and supply to the study reports (interim, final);
Supply 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.
Apply advanced data analytic expertise based on a foundation of statistical principles and applied experience. Use of relevant computational tools for study, experiment, or clinical studies/projects research objectives. Apply high quality statistical methodology in assigned projects with proven understanding of the disease/scientific/functional area.
Ensure application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing detailed specifications to statistical programming colleagues.
Follow organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understand and align with meaningful regulatory mentorship. Take responsibility for the quality and timeliness of project deliverables, as assessed by partners such as the clinical project team, governance committees and the statistics area head. Follow standard methodologies for Data Integrity.
Master’s or PHD degree in Statistics.
Proven experience in clinical development (Pharmaceutical companies, Biotechs or CROs): >10 years of experience
Experience in Pulmonary Hypertension or Cardiovascular is a plus.
Experience in handling the statistical oversight of the external organizations or CROs
You are able to translate business questions into study design, analysis and meaningful results.
Good knowledge of CDISC or common data model
Strong study design and statistical analysis skills
Confirmed hands-on experience with statistical programming languages, e.g. SAS or R.
You are to communicate advanced statistical concepts and results in non-technical terms to a non-statistical audience; ability to formulate complex ad-hoc analysis plans.
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.
Excellent written/oral communication skills, fluent in English