Global Head of Biostatistics and Data Management


  A global biotechnology company, with active presence in Europe, the United States, Russia and China is offering the position of Global Head of Biostatistics and Data Management.

         For a confidential consultation and immediate consideration call Andrea Litovszky on 0044 (0) 207 255 6665 or email your CV to  [log in to unmask]

 

The role would involve


-Line management responsibility for a statistical and data management department.
-Managing and supervising all statistical and data management activities with respect to in-house resources as well as outsourcing (CRO/consulting management)
-Responsible for all clinical trials with respect to statistical and data management activities. This includes clinical trial design/planning, execution, close out and reporting.
-Responsible for statistical input to all major documents, i.e. protocol synopsis, protocol, clinical study report, summary documents, investigator brochure, etc.
-Contribution to scientific discussions, clinical development plan, strategic planning, decision making, ensuring operational requirements are appropriately reflected
-Ensuring compliance to regulatory requirements, including appropriate reflection of guidelines regarding clinical trial analysis and reporting, implementation of standards such as CDISC, preparation of summary documents, etc.
-Ensuring appropriate interaction with health authorities in terms of statistics/strategy, including FDA/EMA meetings, responses to questions, Advisory Committee meetings, etc.
-In addition to management, perform day-to-day statistical tasks as needed
-Ensuring development/providing input to internal processes and standards, including responsibility for functional SOPs
-Establish and maintain sound working relationships and effective communication throughout all levels of the organization as well as with external partners

The ideal candidate would have


-At least Master’s Degree in Statistics (or equivalent degree)
-Fluent English, excellent communication skills
-Knowledge and expertise in theoretical and applied statistics. Knowledge of data management.
-Knowledge and expertise in drug development regulatory guidelines, requirements and standards
-Experience in the pharmaceutical industry for more than 7 years (if an adequate time has been spent on drug development in academia, e.g. university or cooperative group setting, this could compensate for a shorter experience within the drug development industry), including a substantial part within the field of oncology
-Experience in clinical trials through phase 3, including a BLA/NDA development and submission
-Strong management skills

In return


-Exciting strategic position in the heart of Europe at the head quarter
-Be part of a continuously developing global biotechnology company

-Competitive market rate

 

 

                                                         If you would like to apply for the position or wish to learn more about the role and company please:

                                              call Andrea on 0044 (0) 207 255 6605 or email your CV with a brief covering note to  [log in to unmask]

 

 

 

SEC are a Recruitment and Employment Confederation member and ISO9001:2000 accredited specialist recruitment organisation working within the Pharmaceutical, Biotech and CRO industries. If you are interested to learn more about further appointments within Biostatistician roles across the UK and mainland Europe, please contact Andrea on 0044 (0) 20 7 255 6605 for a confidential discussion and immediate consideration.

 

Key words: Clinical Trials, Therapeutic Areas, Clinical Trial Phases, Oncology, CDISC, FDA/EMA, SOPs, Protocol, Compliance, Management, Clinical trial phase I-III

 

 

 


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