For the 2nd year running Kubo will be at the PSI Annual Conference next month!

Kubo are proud for the 2nd year running will be exhibiting at the 2015 PSI conference between the 10th and 13th of May at The Millennium Gloucester Hotel in London. 

This year the PSI Annual conference theme will be "Relevant Applications in a Changing Environment", with a focus on case studies and collaboration.  This will the 38th consecutive annual event which is regarded as the principal annual event for statisticians in the pharmaceutical and healthcare industry in Europe. 

The conference is held over a 3 day period and made up of plenary sessions, parallel sessions (including breakout sessions and sessions for career young statisticians), poster sessions and the annual general meeting. Sessions include data transparency, meta-analysis, estimands, risk-based monitoring, data visualization and many more with speakers from industry, academia and regulatory agencies.

There will 60 speakers over the 3 days a pub quiz and a barn dance! I'm not sure if Kubo will be donning our cowboy boots just yet, but im sure that the event will have a lot to offer and will be a great success!

If you will be attending the event next month make sure you stop by our stand and say hello!

Kubo Recruitment are proud to sponsor the 2014 European Statistical Forum!

Kubo Recruitment are proud to announce that we are sponsoring the 5th annual European Statistical Forum which will be held in Brussels on Monday the 17th of November. 

This year the forum will be focusing on "The current status of the application of
Bayesian Methods in Drug Development" 

In the last years the biostatistics community has increased its interest in the application of Bayesian methodology in drug development as it provides a framework for determining probabilities relevant to inferences from current trials and previous knowledge.

Bayesian statistics has the potential to play an important role throughout the drug/device development process life cycle and in particular in the decision-making process. Its range of applications contains early phase studies, dose- finding, safety analyses, meta-analyses, decision theory as well as the quantification of the benefits and risks essential to health economic evaluation. While the use of Bayesian methodologies has significantly increased in the recent years in exploratory clinical trials, its use in confirmatory clinical trials is still not common.

In total there will be 13 representatives at the Forum all of whom bring considerable expertise and a wide knowledge of the industry. Chairing the discussions will be Frank Fleischer who is the Global BCA at Boehringer Ingelheim Pharma GmbH & Co. Giacomo Mordenti the Senior Director Compound Development & Branding-Head of Biostatistics for Grünenthal, Jens-Otto Andreas who is the Head of EU Biostatistics at UCB Biosciences GmbH and Lisa Comarella who is the Director of Biostatistics and the Senior Project Manager at CROS NT Group. 

The speakers at the forum will be;
Bruno Boulanger- CSO and Company co-founder of Arlenda.
Emmanuel Lesaffre - Professor in Biostatistics and Chair Department of Biostatistics.
Giuseppe Palermo - Statistician at F. Hoffman-La Roche.
Foteini Strimenopoulou - Senior Exploratory Statistician at UCB.
Pantelis Vlachos - Principal Biostatistician at Cytel Inc. 
Heinz Schmidli - Statistical Methodology at Novartis Pharma AG.
Eugène Cox - Vice President & Managing Director for Quantitative Solutions BV.
Nicky Best - Senior Director at Statistical Innovation Group, GSK.
Dominic Magirr - Postdoc, Medical University of Vienna, Center for Medical Statistics and Informatics and Intelligent Systems.

The day promises to be interesting and informative for all industry professionals within biostatistics. Kubo are honoured to be a part of this and look forward to meeting with you. Feel free to call by our stand and introduce yourself during the coffee breaks.

For more information about the ESF and to register visit https://2014-esf.eventify.it/registration  

Guest writer Thomas Zwingers part II- Ask the Experts: Late Phase Oncology Trial Design

Prinicipal Biostatistician Thomas Zwingers hosted Part II of his German-language webinar "Statistical Considerations in Oncology". Part II focuses on statistical methods for early decisions in Phases II and III.

 

According to expert biostatistician Thomas Zwingers, how can adaptive trial design be a method for the future of cancer research? 

 

During Phase III development, efficacy of the drug should be confirmed. Many new products have to find a very specific mechanism of effectiveness, so therefore subpopulations are necessary. Flexible study designs that allow for early termination and the use of fewer patients can be a successful solution for determining clinical efficacy. In oncology trials, we need to take into consideration differentiating factors such as slow patient recruitment, the importance of patient genotype, the use of various treatment combinations and the fact that the primary endpoint is overall survival time or time to progression. 

 

Adaptive Designs in late phase cancer research offer the possibility to make modifications to a study while in progress on the basis of new information pulled from accumulated data. While it is well know that there is the possibility to re-estimate the number of patients needed for a study based on observational data in interim analysis, it is less known that design can allow objectives to be achieved in one study that would normally require the scheduling of two distinct studies, so called "seamless Phase II/III designs".

 

Seamless Phase II/III designs combine two sequential and separate studies into one study and allows the use of collected information in the first stage to adapt the design in the second stage. The advantages of in this design are a reduction in overall time in the development of a drug, fewer patients required, and the early availability of long-term safety data. 

 

Another interesting possibility of an adaptive design is to select the right target population for the drug. This is of special interest in the development of highly specific cancer drugs, which are only effective in selected patient populations - for example, monoclonal antibodies. An adaptive study in Phase II/III may allow for the selection of the most promising target population in the first stage for the second stage.

 

Based on CROS NT's experience in oncology trials, their expert biostatisticians recommend the following for late phase adaptive trials:

- Budget more time for planning of an adaptive design as compared to a standard design
- Interact with regulatory authorities in the planning phase especially for Phase II/III studies
- Use simulations to calculate the power of the sample size and the probability of success
- Evaluate whether or not to stop the recruitment of patients for the interim analyses
- Schedule frequent monitoring visits in order to provide as much data as possible for the interim analyses

About Thomas Zwingers

In Thomas' current role, he provides pharmaceutical, biotechnology and medical device companies with statistical methodology advice pertaining to trial design, conduct and reporting including regulatory submissions. Thomas has been working in the clinical trial environment since 1980 in project team management and statistical analysis. He has particular expertise in Adaptive Designs and Bayesian Framework, Meta-Analysis and Non-Inferiority trials with therapeutic expertise in Oncology, Respiratory and Dermatology.

Wow its March already!!

 

I just can’t believe how quickly this year is going, the daffodils are out and the sun is beginning to show its face a bit longer every day and before you know it, you will be dusting off the BBQ for summer! 

If you feel like you need a change or are looking to progress your career, have a look at some of the job roles Kubo are currently recruiting for!

Senior SAS Programmer- UK

The role is full-time permanent employment in the South East of England.

The candidate will be responsible for producing and validating statistical analysis using SAS. The Senior SAS Programmer has the overall responsibility of the reliability of output produced within a project and is in charge of training and supporting Statisticians and SAS Programmers on programming subjects. http://kuborecruitment.com/jobs/senior-sas-programmer-uk

Quality Assurance Manager - Switzerland

Our client is a rapidly expanding pharmaceutical group located in Switzerland, its strategy focuses on the development and registration of innovative pharmaceutical products. An exciting opportunity has arisen within the Research & Development Division for an experienced Quality Assurance Manager. http://kuborecruitment.com/jobs/quality-assurance-manager-switzerland

Director of Regulatory Affairs- UK & Europe

Are you looking for a dynamic new career opportunity?

To deliver the medical, regulatory and safety strategy for new products and ensure on-going compliance within the total UK/Ireland/Scanda region, leading to the growth of our UK/Ireland/Scanda business. http://kuborecruitment.com/jobs/director-of-regulatory-affairs

ADaM Statistical Expert – USA

Our client is looking for an ADaM statistical expert in the USA with 5+ years work experience in Data Management, Biostatistics or Programming in the Pharmaceutical or Biotech arena. Consultants should have practical experience implementing ADaM and the ability to assist the study teams to create analysis dataset specifications that conform to the ADaM standard (e.g. define dataset, variable, value and results level metadata) and have a strong background in statistics. http://kuborecruitment.com/jobs/adam-statistical-expert-usa

Statistician- Denmark

This is an urgent project. Candidates will be required on site initially for 2-3 months and after this time 50 % home based work is an available option.

The ideal candidate’s will be experienced Statistician’s with at least 2+ years knowledge and experience of the clinical research industry. The candidate’s will be responsible for the design, analysis and reporting of clinical trials and must have good SAS programming skills. http://kuborecruitment.com/jobs/statistician-denmark

Clinical Operations Manager – Switzerland

Our client is a rapidly expanding pharmaceutical group located in Switzerland, its strategy focuses on the development and registration of innovative pharmaceutical products. An exciting opportunity has arisen within the Research & Development Division for an experienced Clinical Operations Manager with 5+ years experience in a similar role and working knowledge of ancillary areas such as data management, statistics, regulatory affairs, etc.

 http://kuborecruitment.com/jobs/clinical-operations-manager-switzerland--3

Please visit www.kuborecruitment to see all our current jobs roles or email andi.brown@kuborecruitment for any further information. 

January Opportunities in Life Sciences

So you have been back at work 2 weeks and like most of us, you are probably sitting at your desk thinking, "where did Christmas and New Years go? I'm back at work already!?!", but are you also at work thinking "I need more!?"

Whether it's more money or more job satisfaction you want, now is the time to do something about it! Kubo Recruitment has many new roles that we are looking to fill!

Deputy Clinical Safety Officer - Permanent - UK
The ideal candidate will provide support to the Clinical Safety & Information Governance Officer (CS & IGO) in order to meet the requirements of GPSoC and other clinical safety deliverables by:

• Ensuring Clinical Safety Documentation is reviewed regularly and kept up to date
• Collating Clinical Safety Information and documentation at the request of external parties
• Providing support to the CS&IGO in the production of Clinical Safety paperwork associated with development projects
• Updating the Clinical Incident Register within the customer database
• Managing and maintaining the Clinical Safety Mailbox

Statistician Required Onsite in Denmark

Two statisticians are required to work onsite in Denmark on a 3-month contract and be open to 50% home-based work thereafter. The ideal candidate will have 3+ years of experience in the industry. 

Associate Director - Statistical Science (Pre-clinical) - Switzerland

Our Client is looking to hire a talented Associate Director, Statistical Science. In this challenging and dynamic role, you will be a global lead for providing the statistical strategy and support of multiple areas within the biomedical research departments. 

Contract CRA - Germany

• Experienced freelance CRA required for a project in Germany covering 6 sites, the majority of the sites are in or around the Munich area. 
• 2-3 days a month over a 5 year period
• Experience with applications BfarM or the EC territory would be an advantage
• Excellent rates

CDISC Consultant/Freelance - Italy

Opportunity for an experienced CDISC consultant/freelance for a short project in Italy:

• To provide operational support to build datasets supporting our client's current eCRD system (designed and built in-house) in a format compatible with CDISC
• Micro-analysis of data structure in order to enable in the future the building of automated datasets compatible with CDISC format

If you would like further information on any of the jobs featured, please contact Rachel Keay at rachel.keay@kuborecruitment.com or visit www.kuborecruitment.com 

European Statistical Forum : Amsterdam, Netherlands

 

The 4th Annual European Statistical Forum (ESF) is taking place on Monday, 18th of November in Amsterdam, the Netherlands. Kubo Recruitment is sponsoring this event which discusses the pressing issues of biostatistics in the pharmaceutical, biotech and clinical trials environment. 

 

The topic of this year's forum is "Missing Data in Clinical Trials".
 

The handling of missing data in clinical trials has become a crucial topic for clinical drug development, in particularly with respect to the regulatory process. New methodologies and techniques have emerged such as mixed-model repeated measures, multiple imputations, pattern-mixture models for longitudinal data as well as specific censoring rules and models for time to event data. 

The ESF 2013 is dedicated to the investigation, exploration as well as handling and analysis of missing data in clinical trials by presenting:

- State-of-the-art statistical methodology
- Case studies from clinical trials showing how missing data can be handled and how they can impact trial results
- Regulatory viewpoints on this topic

 

The ESF Scientific Board includes: Jens-Otto Andreas, Director Global Biostatistics EU Group for UCB Biosciences GmbH, Lisa Comarella, Director, Biostatistics and Senior Project Manager for CROS NT, Frank Fleischer, Global BCA at Boehringer Ingelheim Pharma GmbH & Co. KB, and Giacomo Mordenti, Senior Director Compound Development & Branding-Head Biostatistics at Grünenthal. 

The conference agenda promises a list of prominent speakers from some of Europe's top pharma and biotech companies.

 

Details:

European Statistical Forum
Monday, 18th of November 2013; 09:00 - 17.30
NH Amsterdam Centre
Stadhouderskade 7, Amsterdam, The Netherlands

Thanks for Visiting Us at DIA in Boston, and Remember...We're Hiring!

Kubo Recruitment was pleased to be first time exhibitor at the DIA Annual Meeting in Boston the last week of June. The event was very successful for us as we were able to meet many colleagues in the pharmaceutical and life sciences industry as well as professionals looking for job opportunities in the sector. For Kubo, the DIA Annual Meeting was a chance to introduce ourselves to the North American market and meet potential job candidates for our many job openings there. 

Kubo is also proud to have been a part of the One Fund Boston charity runs held throughout the conference. Organized by CROS NT and Datatrak, the charity 5K runs raised money for One Fund which supports the victims of the Boston Marathon bombings. Kubo's Head of Recruitment, Rachel Keay, ran both runs, and Kubo sold t-shirts at its booth to collect donations. At the end of the conference, $1,615 was raised for One Fund Boston.

Kubo also had the opportunity to co-host a networking event at the New England Aquarium. We would like to thank everyone who came to visit us at this great event. 

Overall, Kubo was very happy with the conference turnout and the quality of job candidates we met at our booth. That being said, we take this time to remind our U.S. job candidates that we do have job openings in your country, including:

• ADaM Statistical Expert: for this role, we are looking for an in depth knowledge and experience of data collection and reporting in drug development and clinical processes, design of ADaM datasets to support complex endpoint analysis, and experience with a variety of study designs. 
• Clinical Data Manager
• Contract Statisticians (on site)
• SAS Statistical Programmer
• Clinical Project Manager/Business Development

Upload your profile to our website to be considered for a position listed above or future positions that match your skills and experience. 

We would like to thank all of those who visited us at our booth during the show, attended our networking event and contributed to One Fund Boston. Kubo is already looking forward to next year's show in San Diego and has already booked its booth space!