3 days ago

Associate Director, Expert Statistician

Actelion Pharmaceuticals Ltd

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Associate Director, Expert Statistician

Associate Director, Expert Statistician - (1700009W) Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of
Johnson & Johnson, is recruiting for Expert Statistician. 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. Actelion is a leader in the field of pulmonary
arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class
(FC) II through to FC IV, with oral, inhaled and intravenous medications. Job Responsibilities

- Independently represent statistics function on global teams (e.g. clinical trial/project or life cycle teams) in
support of clinical trials, indication level programs directly in full compliance with Actelion processes
- Play a leadership role in the development and review of study synopsis, protocol, statistical analysis plan,
clinical study report, and other regulatory submission documents, registration and disclosure of study results in
internal and public registries, ensuring accurate and statistically valid deliverables
- Take ownership of statistical and scientific robustness either directly as a trial statistician, project
statistician, or in a supervisory role
- Manage functionally a group of statisticians and programmers at various levels with respect to deliverables,
processes, and professional development, and mentor staff as required
- Interacts with regulatory authorities on statistical issues on assigned projects/TAs
- Provide Resource Plans and timelines for deliverables for assigned projects
- Be accountable for quality and timeliness of various deliverables and milestones under her/his responsibility
- Lead or support continuous improvement, acceleration and quality of working procedures and outputs in the area of
- Maintain / develop a high standard of statistical methodology

Candidate Requirements

- PhD in Statistics or Life Science, or Master Degree in Statistics or equivalent qualification
- In-depth knowledge in Statistics, and its applications to clinical trials in at least two therapeutic areas
(preferably at least 10 years of experience in clinical trial development in the Pharmaceutical Industry or Clinical
Research Organizations)
- Excellent knowledge of international clinical research regulations and requirements
- At least five years as a Senior Statistician, (i.e., above Statistician level) in Clinical Development in the
Pharmaceutical Industry, or Clinical Research Organizations
- Experience gained in the tasks of Project Statistician (at least 2 years)
- Good project management skills and excellent oral and written communications skills in English
- Good working knowledge and understanding of SAS and of software for sample size estimations
- Advanced knowledge of clinical study designs, common statistical analysis methods, descriptive and inferential
statistics with experience of innovative design and/or analysis methodology implementation in clinical development
- Good knowledge of statistical programming languages (including SAS, R), software, techniques, and processes.
- Working knowledge of UNIX operating systems, and common software products and technologies (e.g., Microsoft Office
- Strong project management skills
- Strong collaborative skills and ability to work with a cross-functional team

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your

Primary Location

: CH-BL-Allschwil


: Clinical Development


: Full-time

Job Type

: Standard

Job Posting

: Nov 21, 2017