Phastar

• Focus on supporting one of our key pharmaceutical clients within our FSP function • Hands-on technical role with oversight responsibilities • Cross functional exposure

• Work as an experienced programmer across multiple clinical studies • Support regulatory submission activities • Produce and validate datasets and outputs • Program and validate datasets and SDTMs • Program complex non-efficacy outputs/figures • Perform Senior Review and Deliver QC of non-statistical output • Coordinate and perform code reviews • Create, QC and update complex dataset specifications • Act as a Lead programmer on multiple studies and projects • Develop archiving systems and processes

• As a Senior Statistical Programmer, you will be working embedded within the sponsor FSP team. • This role will be using both SAS & R Programming within the clinical domain. • Program and validate datasets and SDTMs, including complex efficacy, labs, etc. • Adhere to client SOPs and work on client systems • Oversight of Vendor Programming • Knowledge of FDA CRT requirements including define.xml • Lead Team and be responsible for creation of CRT packages • Perform R Programming on Datasets • Program complex non efficacy outputs and figures • Perform senior review and deliver QC of non-statistical output • Create, QC and update complex dataset specifications

• Lead late phase, non-interventional, observational and medical studies • Transform clinical and Real World Data (RWD) into analysis read datasets • Generate Tables, Listings and Figures (TLF) • Ensure analysis is reliable and accurate to support publications, submissions and medical insights • Work cross-functionally along side the Medical Affairs team • Programming SDTM and ADaM datasets and working within CDISC standards • Utilize R Shiny and Python to visualize data • Clean and manage datasets to maintain compliance and accuracy

• Work as a principal programmer 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) • Ensuring the principles in the PHASTAR checklist are followed rigorously • Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery

• Program and validate datasets and SDTMs, including complex efficacy, labs, etc. • Program complex non efficacy outputs/ figures • Perform Senior Review and Deliver QC of non- statistical output • Develop and debug complex macros • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study • Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc • Review more complex 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 • Lead team and be responsible for creation of CRT packages • Become familiar with and follow study documentation • Lead a team for furthering programming development • Ensure the principles in the PHASTAR checklist are followed rigorously • Archive study documentation following instructions in supplied SOPs • Act as a Lead programmer on multiple studies under same 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 • Create, review and update processes and SOPs • Take responsibility for study compliance with SOPs and processes

• Program and validate datasets and SDTMs, including complex efficacy, labs, etc • Program complex non efficacy outputs/ figures • Perform Senior Review and Deliver QC of non- statistical output • Develop and debug complex macros • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study • Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc • Review more complex 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 • Lead team and be responsible for creation of CRT packages • Become familiar with and follow study documentation • Lead a team for furthering programming development • Ensure the principles in the PHASTAR checklist are followed rigorously • Archive study documentation following instructions in supplied SOPs • Act as a Lead programmer on multiple studies under same 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 • Create, review and update processes and SOPs • Take responsibility for study compliance with SOPs and processes

• Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. • Program and validate datasets and SDTMs, 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 • Responsible for study level resources • Point of contact for programming issues for the team, proactively ensuring everything is working cohesively

• Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. • Program and validate datasets and SDTMs, 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 • Responsible for study level resources • Point of contact for programming issues for the team, proactively ensuring everything is working cohesively

• 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 a 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