Associate Director Biometrician – Switzerland

Priya Mukherjee at CK Clinical is recruiting for an Associate Director Biometrician required to work for

a leading pharmaceutical organisation in Switzerland.

Responsibilities:

The Associate Director Biometrician is responsible for providing expert statistical analytic solutions across multiple disease areas within a Franchise or equivalent and able to seamlessly move across the portfolio within a Franchise. They are responsible for statistical analytic support to clinical development programs, mentoring other biometricians stretching through to the full spectrum of capabilities

Main Responsibilities:

  • Lead the statistical analytic contributions to the clinical development programs within a Franchise, in collaboration with the Statistical Scientist, comprising all relevant technical and disease area knowledge.
  • Drive in developing statistical strategic quantitative contributions to regulatory/ submission strategy and related documents via expert statistical analytic solutions with excellent interface to the Statistical Scientist: Decision criteria, CSPDs, MAPs, project development strategy and trial designs, responses to HA questions.
  • Be responsible for leading statistical analytic solutions for regulatory submissions and health authority interactions, by working with statistical scientists and programmers.
  • Provide expert statistical analytic support to the Statistical Scientist in developing the pooling strategy specifically for compounds that are developed for multiple indications within a Franchise and develops the detailed statistical methodology for the MAP, CSPDs and attend submission planning meetings.
  • Represent biometrics at the GPT meetings and other internal decisions boards in collaboration with the Statistical Scientist.
  • Provide statistical computational expertise for scenarios simulations to optimize program/trial and analysis strategies through to sample size and probability of success calculations in collaboration with the Statistical Scientists for CDP writing.
  • Provide expertise specifically to high complexity programs to execute the CSPD, advisory committee tables, figures and listings.
  • Ensure high quality for all deliverables and processes.
  • Foster efficient expert interfaces with internal and external customers with support of management.
  • Drive statistical research in collaboration with statistical scientists and the commercial organization by providing expertise and trouble shooting on computational statistical aspects of the problem.
  • Lead the statistical analytic solutions to the exploratory analyses.
  • Define future directions for computational solutions / liaises with programming defining future generic code.
  • Maintain strong and broad based statistical expertise – maintain knowledge of mainstream and newly emerging statistical /numerical techniques / algorithms.
  • Take leadership in influencing internal discussions for white papers for general analytic practice internally and establishing external presence.
  • Drive, steer and mentor others, and may undertake role of development/appraisal coordinator for selected Franchise associates.

Qualifications and skills:

To be considered for this Associate Director Biometrician role the successful candidate will have the following qualifications and experience:

  • Proven in up-to-date statistical knowledge/ applications and expert in analytic aspects. A deep understanding of drug development and HA guidelines.
  • Excellent knowledge of / experience with SAS/ R/ Splus or any other business or research analytic software
  • Establish record in operating at program level
  • Strong interpersonal and communication skills (verbal and written), strong disease area knowledge
  • Strong team skills.
  • Establish track record of trouble shooting skills including significant regulatory/ decision making support
  • Natural modern leadership style building partnerships and collaborative environments.

HPriya Mukherjee - European Operations Managerow to apply:

Apply online:

For more information or to apply for this Associate Director Biometrician role please contact Priya Mukherjee on +44 (0) 2074 705 673 or email pmukherjee@ckclinical.co.uk. Please quote reference CL25348 in all correspondence.

 

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Our Latest Pharmaceutical Jobs – 01/10/2012

Looking for a new job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

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style=”padding-top: 25px;”>European jobs:

(Senior) CRA – The Netherlands

Associate Director Biometrician – Switzerland

Senior CRA – Belgium

Clinical Scientist – Switzerland

Global Regulatory Manager – Switzerland

Expert Clinical Manager – Switzerland

Medic:

Principal Scientific Expert (MD) Respiratory

Regulatory Affairs:

Regulatory Affairs Co-Ordinator

Regulatory Affairs EU Region Lead

RA Cross Regional Excellence Lead

Clinical:

Senior Associate, Study Management

Senior Study Managment Associate – Berks

Clinical Project Director – London

Clinical Administration Coordinator – Cambridge

CRA Training Manager – Homecounties

 

Register your CV with CK Clinical

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt

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Biometric roles in the UK and Europe:

Here are a few of our latest Biometric roles in the UK and

Europe:

Click on the links to find out more about the roles:

 

SAS and JAVA project Leader – Belgium

Mylene Paumier is recruiting for a SAS and JAVA project Leader to join an international contract research organization at their site based in Belgium on a contract basis

Click here to find out more

 

Data Analyst Statistician – Middlesex

Mylene Paumier is recruiting for a Data Analyst Statistician to join a global pharmaceutical company at their site based in Middlesex on a contract basis

Click here to find out more

 

Senior Clinical Operations Manager – Germany

Mylene Paumier is recruiting for a Senior Clinical Operations Manager to join a global pharmaceutical company at their site based in Germany on a permanent basis

Click here to find out more

How to apply:

For more information or to apply for any of these roles please contact Mylene Paumier on 0207 4705675 or email mpaumier@ckclinical.co.uk

 

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Our Latest Pharmaceutical Jobs – 24/09/2012

Looking for a job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

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dding-top: 25px;”>RegulatorCK Clinical Recruitment UK and Europey Affairs:

RA Cross Regional Excellence Lead

Hub Labelling Manager

Regulatory Operations Specialist

Regulatory Affairs Project Manager

Drug Safety:

Pharmacovigilance Medical Writer

Senior Medical Information Scientist (contract)

Global Pharmacovigilance Regional Head

Medical Information Associate

Clinical:

Senior Biosamples Operations Manager

Biometrics:

Senior Business Analyst

Senior Clinical Operations Manager

 

Register your CV with CK Clinical

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt

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Pharma Companies Solve ClinicalTrial Inefficiencies

As reported by The Pharma Times, ten of the world’s top pharma companies have come together to form Tran

sCelerate BioPharma

, with the aim of combatting inefficiencies in clinical trials.

This is the largest ever initiative of this kind and will involve the following pharmaceutical companies will be involved:

 

Over the past few decades, the productivity of research and development within the pharmaceutical industry has been declining whilst the costs have been steadily rising. In fact, it is estimated that about 5,000 to 10,000 potential drugs fail for every one that is approved. In addition, the cost of getting a drug approved has risen from $140m in the 1970s to over $1.2 billon. One reason for this increase is the time it takes from finding a compound to getting it approved by regulators – which can take between 10 to 15 years.

Therefore, the aim of TransCelerate is to shorten this time whilst reducing costs. This is explained by TransCelerate Head, Gary Neil: “It will enable everybody to develop new drugs faster and better. If this helps to reduce costs, then maybe we can investigate more drugs.”

Looking for a new position in the pharmaceutical industry?

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10 Global Pharma Companies Collaborate to Solve Clinical Trial Inefficiencies 10 Global Pharma Companies Collaborate to Solve Clinical Trial Inefficiencies 10 Global Pharma Companies Collaborate to Solve Clinical Trial Inefficiencies 10 Global Pharma Companies Collaborate to Solve Clinical Trial Inefficiencies

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Roche leads healthcare sustainability for 4th year

WorldPharmaNews has reported that Roche has been recognised as the most sustainable healthcare company globally in the Dow Jones Sustainability Index for the fourth year in a row

The Dow Jones Sustainability Index World is the most widely accepted global assessment of how companies approach their social, economic and environmental responsibility. It monitors the performance of the leading sustainability companies based on a best-in-class approach in environmental, social and economic performance.

Severin Schwan, CEO of Roche said “Roche’s ranking as the most sustainable healthcare builds on the continued efforts do business in a way that benefits all our stakeholders. Roche is committed to engaging with communities, patients and public health in a way that creates long-term value for everyone”

 

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GSK & Cambridge Develop Drugs for Disease

News Medical has reported that a new collaboration between the University of Cambridge and GSK will aim to discover and develop new medicines to treat liver disease.

The collaboration with GSK will combine Professor Lomas’ long-term research at the University of Cambridge Institute for Medical Research (CIMR) with GSK’s expertise in drug discovery and development in order to develop new therapeutics. Work on the project will be carried out both at GSK and at the CIMR.

This new partnership will build upon the work of researchers who have identified a molecular mechanism that plays a major role in the life-threatening liver disease that develops in patients with a particular mutant gene.

Alpha-1 antitrypsin (A1AT) deficiency is one of the most common genetic disorders in the UK, affecting approximately one in 2,000 people. Professor Lomas said that “Currently, the only option for patients with liver disease as a result of alpha-1 antitrypsin deficiency is transplantation…….This partnership brings together our collective expertise in target biology and drug discovery to tackle an unmet medical need and by teaming up with GSK, we have a great opportunity to turn our research into effective treatments”

 

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Our Latest Pharmaceutical Jobs – 10/09/2012

Looking for a job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

 

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mg class=”alignright size-thumbnail wp-image-9270″ title=”” src=”http://ckclinical.co.uk/wp-content/uploads/2012/09/shutterstock_88026736-150×150.jpg” alt=”” width=”150″ height=”150″ />Drug Safety:

PV Project Manager – Hertfordshire

Medical Science Liaison – South West

Senior Pharmacovigilance Officer – Berkshire

 

Clinical:

Clinical Study Manager, Hertfordshire

Clinical Research Associate – North England

Clinical Research Nurse – Salford

Senior Quality Assurance Auditor in London

Clinical Trial Head, Oncology, Switzerland

Clinical Trial Assistant

 

Medic:

Interim Med Affairs Advisor – Cambridge

 

Regulatory Affairs:

Senior Manager, EU Reg Affairs

Senior Associate, EU Reg Affairs

Regulatory Affairs Manager – Switzerland

 

Register your CV with CK Clinical

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt

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Icon Plc partnership with College Dublin

Pharmatimes have reported that Icon plc have joined a strategic alliance with the University College Dublin to advance research

Icon have said that this new partnership supports a shared vision for transforming research, teaching, training and innovation in the sciences in Ireland and aims to strengthen the ties between academic research and industry.

Icon have established the ICON Newman Fellowship in Genomics as one component of the partnership. This will be a two-year post-doctoral fellowship based at the UCD School of Medicine and Medical Science and at the College’s Complex and Adaptive Systems

Also ICON and the University College Dublin will work collaboratively on ways to enhance drug development.

The partners said that “This programme has “the potential to include tailored teaching programmes and internships in clinical research that will be available in Ireland and internationally through some of UCD’s university partners”,

 

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Boehringers new lung drug promises success for COPD

Pharmatimes has reported that Boehringer Ingelheim’s new lung drug tiotropium in the Phase III data trial significantly reduced exacerbations and improved both lung function and quality of life.

The results of the trial showed that the drug could cut the risk of severe asthma exacerbation by 21% in patients who remain symptomatic despite receiving treatment for the disease.

Sttudy author Professor Huib Kerstjens of the University Medical Centre, Groningen said “While we were anticipating improvements in lung function when adding tiotropium to usual care, the significant reduction in the risk of exacerbations came as a surprise – especially given that all patients were already receiving optimal maintenance treatment as defined by the GINA guidelines”

 

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