Job Detail

Real World Evidence (RWE) Senior Statistician - (180000B4) 

Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for aSenior/ExpertReal World Evidence (RWE) Statistician in Allschwil. Other locations may be considered.

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 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.

Role Summary

The senior/expert RWE statistician provides lead support for the design, execution, analysis, interpretation, and reporting or communication of data evidence for real world evidence 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.

Role Responsibilities

• Provide statistical expertise at all stages of the design and implementation of observational outcomes projects (e.g. patient registries, post approval safety studies…) from planning and design through to completion, in close collaboration with multi-disciplinary research teams:


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  • provide input into the concept, design and development of observational 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;
  
  
  • perform analyses aimed at integrating multiple sources of evidence to inform study design;
  
  
  • provide statistical insight in the interpretation and discussion of study results, and contribute to the study reports (interim, final);
  
  
  • contribute to study reports and publications;
  
  
  • manage the statistical CROs and external partners;
  
  
  • plan for, deliver and be accountable for all statistical outputs and their quality
  
  


• Contribute to the submission plans, strategy and analyses involving RWE data


• 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 demonstrated 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.


• Provide thought leadership in statistics and RWE, ensuring scientific validity and overall quality and accuracy of results.


• Optimize methodological expertise: maintain professional statistical standards by keeping track of new developments in statistical methodology and outcomes research, through literature review and attendance/participation at workshops and professional meetings.


• Communicate analysis results through internal/external presentations and publications. 


• Comply with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understand and align with relevant regulatory guidance. Take responsibility for the quality and timeliness of project deliverables, as assessed by stakeholders such as the project team, the project and RWE team, and the statistics area head. Follow best practices for data integrity.


• Leads process improvement or standards development initiatives. Provides input into hiring decisions and ongoing evaluation of talent.

 

Candidate Requirements

• Master’s or PHD degree in statistics, epidemiology, or related field. Strong methodological and statistical background.


• Demonstrated experience in clinical development (pharmaceutical companies, biotech’s or CROs): >3 (senior) to >8 (expert) years of experience.


• Experience in biostatistics or statistics applied to real world evidence or epidemiology, with expertise in developing, conducting and analyzing patient registry data is a plus.


• Experience in pulmonary hypertension or cardiovascular disease is a plus.


• Experience in managing the statistical oversight of the external partners or CROs


• Being able to translate business questions into study design, analysis and relevant results.


• Good knowledge of CDISC or common data model.


• Strong study design and statistical analysis skills: demonstrated knowledge of biostatistics and epidemiology principles (observational study design and analysis); advanced technical expertise to design and perform outcome research projects; excellent knowledge in applied statistics and data analysis methodology. Experience in performing real world outcomes research/comparative effectiveness based on registries in a pharmaceutical environment is a plus.


• Solid hands-on experience with statistical programming languages, e.g. SAS and R.


• Ability 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 manage multiple projects under tight deadlines.


• Excellent written/oral communication skills, fluent in English.

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

 

Primary Location

: CH-BL-Allschwil

Job

: Clinical Development

Schedule

: Full-time

Job Type

: Standard

Job Posting

: Aug 1, 2018