Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Statistician, remote to join our client-based team. This is for one of the leading global biopharmaceutical companies, with a focus on Neurology and Immunology.

Job specific tasks and responsibilities:

• Serving as a statistical study lead, driving statistical input in one or more individual clinical studies within a clinical program or across multiple clinical programs
• Providing guidance on study design and appropriate statistical input on all aspects of analysis, interpretation of findings and reporting of results
• Giving technical oversight of deliverables outsourced to external CRO's or vendors
• Producing and reviewing statistical deliverables for a submission or other regulatory interactions
• Performing exploratory statistical analysis to gain novel insight that can be used to help inform the development of existing or new compounds
• Working effectively with cross-functional teams, working collaboratively with teams within and across therapeutic areas, to deliver appropriate support
• Driving and delivering statistical excellence to non-clinical development in Preclinical and Research areas
• Actively driving innovation within the global team
• Seeking information from the internal and external environment to understand the wider business, scientific and/or commercial context

Clinical

• Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs
• Gives input into the study design, efficacy and safety parameters and the planned statistical analyses
• Performs simulations to support choice of study design, decision rules and the sample size Participates in protocol development if this is not delegated to an external partner biostatistician
• Reviews the protocol prepared by the external partner biostatistician
• Supports or oversees external partner biostatistical support for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results. This includes input into randomization specifications, statistical analysis plans, interim analyses, safety reviews and final analyses
• Communicates and coordinates all statistical activities with external partner biostatisticians
• Provides input on interpretation of results
• Reviews and inputs into the clinical study report
• Assists the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound
• Effectively contributes within cross-functional or multi-disciplinary groups.
• Stays current with ongoing developments in statistical methods applications in the pharmaceutical industry
• Acts as a resource for other biostatisticians
• Communicates complex issues in nontechnical language by using visuals, simulations and other illustrative techniques
• Provides statistical sciences training to colleagues from different disciplines on statistical concepts
• Contributes and reviews abstracts, posters, presentations and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents

Requirements:

• Master degree in statistics, PhD in statistics is a plus
• Very good knowledge of multivariate analysis (regression analysis, PCA, PLS), multivariate statistical process control and experimental designs
• Knowledge about the prediction of data in time series (i.e. via bootstrapping or lag-KNN) is a plus
• Proficiency with R, JMP and SAS (base, stat) is expected. Other statistical packages knowledge is an asset (SIMCA, …)
• Some background in Pharmaceutical R&D and Manufacturing
• Experience in multidisciplinary projects

Skills:

• Good customer oriented view
• Flexibility
• Willingness to develop a good base understanding (not directly linked to statistics) of the different supported areas (analytical chemistry, process chemistry, etc)
• Capable to deal with very different issues coming from different areas at the same time.
• Good communication and teaching skills

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002461

or please contact Rocio.EgeaMota@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Statistician, Statistics, Biostats, Early Development, Late Development, remote
Skills: Biostatistician Location: United Kingdom Share:

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