71 days ago on jobs.actelion.com

Expert Statistician

Actelion Pharma Schweiz AG

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Expert Statistician

Expert Statistician - (160000HY)
 

 

About the Company

 

Actelion Pharmaceuticals Ltd. is a leading biopharmaceutical company employing over 2,500 dedicated professionals covering all key markets around the world – including Europe, the US, Japan, China, Russia and Mexico. Headquartered in Allschwil, near Basel, Switzerland, our functional, award-winning Actelion Center is a symbol of our innovative spirit and culture.

 

We are searching for breakthrough medicines for high unmet medical needs and this inspires and motivates all of us to work towards achieving our overriding mission: to treat more patients with groundbreaking therapies.

 

Besides highly competitive compensation and tangible benefits, would you like to have a noticeable impact and enjoy our culture of innovation, trust and teamwork? Do you want to grow in a different kind of company with an enthusiastic, stimulating environment fostered by open communication and a results-driven approach? Then we welcome your application to join our team in the role of Expert Statistician, based in Allschwil.

 

  Job Responsibilities

  • Actively participate in and contribute to decision making related to clinical development strategies, regulatory and commercial strategies
  • Independently represent statistics function on global teams in support of clinical studies, 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, ensuring accurate and statistically valid deliverables
  • Study supporting clinical development objectives
  • Plan and direct compound level analysis and reporting activities (e.g. tables, listings, graphs) including work of other statisticians and programmers
  • Define vendor requirements and participate in the evaluation/selection of vendors. Manage activities of external vendors to ensure timeliness and quality of statistical outputs
  • Ensure review and approval of statistical deliverables
  • Identify and interact with external statistical experts for issues related to study design, methodology and results
  • Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program
  • Propose and implement solutions, escalate issues to management as appropriate in a timely manner
  • Contribute to the implementation of department standards and process improvements
  • Promote and use innovative statistical methodology in the design and analysis of clinical Lead evaluation and implementation of alternative analysis methodology and data presentation techniques
  • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, implement innovative approaches at a compound level
 

Candidate Requirements

  • PhD in statistics or biostatistics with minimum of 8 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics with minimum of 10 years of relevant pharmaceutical industry experience
  • Track record in supervision and operational management of project teams (statistician and programmers) in full autonomy, with demonstrated leadership and excellent oral and written communications skills in English
  • Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics with experience of innovative design and/or analysis methodology implementation in clinical development
  • Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions, and experience with at least one NDA/CTDs or other global regulatory submissions
  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
  • Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products)
  • Strong project management skills
  • Strong collaborative skills and ability to work with a cross-functional team

 What Actelion Offers

  • A competitive salary and generous social benefits
  • The possibility for development and advancement within our dynamic organization
  • The innovative and stimulating atmosphere of a multicultural environment

 

The research facilities are located in Allschwil, Switzerland, a suburb of Basel on the borders of France and Germany.

 

 

Primary Location

: CH-BL-Allschwil

Job

: Clinical Development

Schedule

: Full-time

Job Type

: Standard

Job Posting

: Sep 27, 2016