Employees may be required to perform some or all of the following... Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc. Program complex non efficacy outputs/figures Develop and debug complex macros Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies Review simple study design SAP without supervision Review all shells without supervision and provide feedback Knowledge, interpretation and implementation of current SDTM, ADaM standards Knowledge of FDA CRT requirements including define.xml and define.pdf Become familiar with and follow study documentation Ensure the principles in the Phastar checklist are followed rigorously Archive study documentation following instructions in supplied SOPs Act as a Lead Programmer, ensuring quality and timely delivery Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables Assess and monitor study level resources Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Assist in development of internal training courses Qualifications Educated to BSc or above within Computer Science, Mathematics or a Science related discipline 5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs) 5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential) ISS/ISE experience (essential) Excellent communication skills Good awareness of clinical trial issues, design, and implementation Familiarity with GCP and regulatory requirements

Employees may be required to perform some or all of the following: Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Identify macros requirements, communicate and perform training Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc Implement and coordinate development and maintenance of PHASTAR standard specifications Be an SDTM and ADAM expert providing consultancy, advice and training Be an CRT expert providing consultancy, advice and training Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements Implement and coordinate the development and maintenance of PHASTAR CRT tools Become familiar with and follow study documentation Initiating projects and ideas for furthering programming development Ensure the principles in the PHASTAR checklist are followed rigorously Develop archiving systems and processes Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery Liaise with Study Statistician and Project Manager regarding resourcing and deliverables Responsible for study level resources Attend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update processes and SOPs Take responsibility for study compliance with SOPs and processes Qualifications Educated to BSc or above within Computer Science, Mathematics or a Science related discipline SAS Programming Experience within the pharmaceutical industry Good awareness of clinical trial issues, design, and implementation. Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISC standards

THE ROLEDemand for our Functional Service Provision is growing we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with ISS / ISE and submission experience, who is versatile and flexible to work on various therapeutic areas. The successful individual must be able to program / QC ISS and ISE datasets, as well as TLFs – and will have experience with building macros and standards.This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.This position is remote, and the successful candidate can be located anywhere in India.Responsibilities:Employees may be required to perform some or all of the following...Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc.Program complex non efficacy outputs/figuresDevelop and debug complex macrosCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studiesReview simple study design SAP without supervisionReview all shells without supervision and provide feedbackKnowledge, interpretation and implementation of current SDTM, ADaM standardsKnowledge of FDA CRT requirements including define.xml and define.pdfBecome familiar with and follow study documentationEnsure the principles in the Phastar checklist are followed rigorouslyArchive study documentation following instructions in supplied SOPsAct as a Lead Programmer, ensuring quality and timely deliveryLiaise with the Study Statistician and Project Manager regarding resourcing and deliverablesAssess and monitor study level resourcesPoint of contact for programming issues for the team, proactively ensuring everything is working cohesivelyPersuade stakeholders to follow best practice within a trialAssist in development of internal training coursesQualifications:Educated to BSc or above within Computer Science, Mathematics or a Science related discipline5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs)5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential)ISS/ISE experience (essential)Excellent communication skillsGood awareness of clinical trial issues, design, and implementationFamiliarity with GCP and regulatory requirementsOncology experience is strongly preferred. Candidates without oncology experience must have prior experience working on complex efficacy studies.APPLY NOWWith the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in India as this role can be carried out remotely.Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.Important notice to Employment businesses/AgenciesPhastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

THE COMPANYPhastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.Our unique approach to data analysis, The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.WHY PHASTARAccredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!THE ROLEDemand for our Functional Service Provision is growing, therefore we are looking for an experienced, ambitious and driven Programmer to join our FSP team The expectation is that the candidate has very strong CDISC knowledge. We're looking for a skilled QC expert with strong experience in ADaMs and TLFs, along with solid SDTM knowledge. This role requires independent work, client coordination, and proactive problem-solving.This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.ResponsibilitiesEmployees may be required to perform some or all of the following:Program and validate datasets and SDTMs, including complex efficacy, labs, etc.Become independent technical expertProgram complex non efficacy outputs/ figuresPerform Senior Review and Deliver QC of non- statistical outputBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyValidate and perform User Acceptance Testing (UAT) on standard macrosCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etcImplement and coordinate development and maintenance of PHASTAR standard specificationsBe an SDTM and ADAM expert providing consultancy, advice and trainingBe an CRT expert providing consultancy, advice and trainingBe aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirementsImplement and coordinate the development and maintenance of PHASTAR CRT toolsBecome familiar with and follow study documentationInitiating projects and ideas for furthering programming developmentEnsure the principles in the PHASTAR checklist are followed rigorouslyAct as a Lead programmer on multiple studies and project, ensuring quality and timely deliveryLiaise with Study Statistician and Project Manager regarding resourcing and deliverablesResponsible for study level resourcesAttend and input to company resourcing meetingPoint of contact for programming issues for the team, proactively ensuring everything is working cohesivelyPersuade stakeholders to follow best practice within a trialDevelop and deliver company-wide training as and when requiredIdentify areas where new processes are requireQUALIFICATIONS & EXPERIENCEBSc or above in mathematics, science, or IT related discipline.Experience working on clinical trials within a CRO/pharmaceutical environment.Excellent proven end to end programming experience including SDTM, ADaM and TLFs with solid experience of validating/reviewing outputsStrong QC ability across ADaMs and TLFs predominantly but good SDTM experience neededAbility to work independently and link in with client for work assignments, updated FSP manager on progress/timelines/challenges and feedback QC comments to third party vendorMust be able to work autonomously as there is no overlap with client teams based in US for day-to-day communication. Has to feel comfortable prioritising tasks and being able to investigate issues and suggest solutionsAPPLY NOWWith the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.Should you feel that you have the right skill set and motivations for this position, please apply!Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.Important notice to Employment businesses/ AgenciesPhastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

OverviewTHE COMPANYPhastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.Our unique approach to data analysis, The Phastar Discipline, has led us to build a reputation for outstanding quality. With this as our core focus, were looking for talented individuals who share our passion for quality and technical expertise to join our team.WHY PHASTARAccredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.Whats more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, youll also be helping to save the planet!THE ROLEWe are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment.This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year. ResponsibilitiesProgram and validate datasets and SDTMs, including complex efficacy, labs, etc.Become independent technical expertProgram complex non efficacy outputs/ figuresPerform Senior Review and Deliver QC of non- statistical outputBecome involved in developing the standard macro library and take responsibility to implement standard macros within a studyValidate and perform User Acceptance Testing (UAT) on standard macrosIdentify macros requirements, communicate and perform trainingCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc.Implement and coordinate development and maintenance of PHASTAR standard specificationsBe an SDTM and ADAM expert providing consultancy, advice and trainingBe an CRT expert providing consultancy, advice and trainingBe aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirementsImplement and coordinate the development and maintenance of PHASTAR CRT toolsBecome familiar with and follow study documentationInitiating projects and ideas for furthering programming developmentEnsure the principles in the PHASTAR checklist are followed rigorouslyDevelop archiving systems and processesAct as a Lead programmer on multiple studies and project, ensuring quality and timely deliveryLiaise with Study Statistician and Project Manager regarding resourcing and deliverablesResponsible for study level resourcesAttend and input to company resourcing meetingPoint of contact for programming issues for the team, proactively ensuring everything is working cohesivelyPersuade stakeholders to follow best practice within a trialDevelop and deliver company-wide training as and when requiredIdentify areas where new processes are requiredCreate, review and update processes and SOPsQualifications Ability to lead Able to work on complex programmingISS/ISE experience preferredHave written complex macros. Educated to BSc or above within Computer Science, Mathematics or a Science related discipline APPLY NOWWith the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely.Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.Important notice to Employment businesses/AgenciesPhastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

THE ROLEDemand for our Functional Service Provision is growing we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with ISS / ISE and submission experience, who is versatile and flexible to work on various therapeutic areas. The successful individual must be able to program / QC ISS and ISE datasets, as well as TLFs – and will have experience with building macros and standards.This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment.This position is remote, and the successful candidate can be located anywhere in India.Responsibilities:Employees may be required to perform some or all of the following...Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc.Program complex non efficacy outputs/figuresDevelop and debug complex macrosCreate, QC and update complex dataset specifications (including efficacy) for single/ multiple studiesReview simple study design SAP without supervisionReview all shells without supervision and provide feedbackKnowledge, interpretation and implementation of current SDTM, ADaM standardsKnowledge of FDA CRT requirements including define.xml and define.pdfBecome familiar with and follow study documentationEnsure the principles in the Phastar checklist are followed rigorouslyArchive study documentation following instructions in supplied SOPsAct as a Lead Programmer, ensuring quality and timely deliveryLiaise with the Study Statistician and Project Manager regarding resourcing and deliverablesAssess and monitor study level resourcesPoint of contact for programming issues for the team, proactively ensuring everything is working cohesivelyPersuade stakeholders to follow best practice within a trialAssist in development of internal training coursesQualifications:Educated to BSc or above within Computer Science, Mathematics or a Science related discipline5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs)5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential)ISS/ISE experience (essential)Excellent communication skillsGood awareness of clinical trial issues, design, and implementationFamiliarity with GCP and regulatory requirementsOncology experience is strongly preferred. Candidates without oncology experience must have prior experience working on complex efficacy studies.APPLY NOWWith the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in India as this role can be carried out remotely.Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.Important notice to Employment businesses/AgenciesPhastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.