Principal Statistical Programmer
3 weeks ago
About thejob
AboutPhastar
Phastar brings data tolife We are an awardwinning specialist biometrics contractresearch organization (CRO) that works with pharmaceuticalbiotechnology and medical device companies to provide statisticalconsulting analysis and reporting data management and data scienceservices.
Our unique approach to data analysisThe PHASTAR Discipline has gained us a reputation for outstandingquality. With this as our core focus were looking for a talentedindividual who shares our passion for quality and technicalexpertise to join our teamcould this beyou
WhyPhastar
Phastar is a company thatcares. We strive to be the premier biometrics provider to work withand to work for and we take our responsibility to do our part forthe environment and our community seriously.
Ourpro bono scheme provides charities access to our biometrics expertsat no cost; we source sustainable products to reduce our carbonfootprint and when you join our team we will plant a tree in yourhonour as part of our rewilding project. Learn more about our ESGinitiatives here.
Caring forYOU
YOUR career YOUR work/lifebalance YOUR PHASTAR experience.
Totalflexibility working hours that work for YOU.
Remote working arrangement that works for YOU.
Culture of learning continuously develop YOUR knowledge and shareYOUR expertise with others.
Career Path tailoredto YOUR strengths and aspirations.
Monthlywellbeing checks to ensure you get the support youneed.
Fun friendly working environmentexperience PHASTARs famous social events throughout theyear.
Sound a good fit for you Hereare some of the key contributions you would be making as a fullyintegrated member .
Program andvalidate datasets and SDTMs including complex efficacy labsetc.
Become independent technicalexpert
Program complex non efficacy outputs/figures
Perform Senior Review and Deliver QC ofnon statistical output
Become involved indeveloping the standard macro library and take responsibility toimplement standard macros within a study
Validate and perform User Acceptance Testing (UAT) on standardmacros
Create QC and update complex datasetspecifications (including efficacy) for single/ multiple studiesISS/ISEs etc
Implement and coordinatedevelopment and maintenance of PHASTAR standardspecifications
Be an SDTM and ADAM expertproviding consultancy advice and training
Be anCRT expert providing consultancy advice andtraining
Be aware of up and coming changes toCRT and define.xml standards and regulatory guidelines andrequirements
Implement and coordinate thedevelopment and maintenance of PHASTAR CRT tools
Become familiar with and follow studydocumentation
Initiating projects and ideas forfurthering programming development
Ensure theprinciples in the PHASTAR checklist are followedrigorously
Act as a Lead programmer on multiplestudies and project ensuring quality and timelydelivery
Liaise with Study Statistician andProject Manager regarding resourcing anddeliverables
Responsible for study levelresources
Attend and input to company resourcingmeeting
Point of contact for programming issuesfor the team proactively ensuring everything is workingcohesively
Persuade stakeholders to follow bestpractice within a trial
Develop and delivercompanywide training as and when required
Identify areas where new processes arerequire
QUALIFICATIONSEXPERIENCE
BSc or above inmathematics science or IT related discipline.
Experience working on clinical trials within a CRO/pharmaceuticalenvironment.
Ability to engage and interact withglobal and local teams embedding into the clientteams
Proactive and solutionsorientated
Oncology experience preferred but notmandatory
Demonstrable leadership skillsincluding providing oversight of deliveries
Excellent proven end to end programming experience including SDTMADaM and TLFs with solid experience of validating/reviewingoutputs
Please use the below link for jobapplication and quickerresponse.
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