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Sr Programmer Analyst (FSP)

Pharmaceutical Product Development (PPD)

Multiple Locations

Sr Programmer Analyst (Client Dedicated) - Home based UK/Europe - €/£7,000 Joining Bonus

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our Biostatistics & Programming department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

We are currently recruiting for an experienced Senior Programmer I/II to join PPD, workingdedicated to one of our Biotech clients.Asa Sr Prog you will work directly with the client as part of their team. Supporting the biostatistician and the project team for diverse statistical/programming tasks, and supporting the clinical development programs within the client setting. The tasks mainly focus on programming statistical analysis datasets, outputs and performing the QC thereof. Another major task is ensuring CDSIC compliance of ADaM datasets. In addition to supporting the biostatistician, the Statistical Programmer provides programming support towards Data-Management. Responsibilities include: Provides relevant input in the development of the statistical analysis plan and mock tables, listings and figures. Performs critical review of derived datasets specifications and derived datasets (ADaM). Develops programs to perform QC of statistical outputs. Defines program specific standards for ADaM datasets. Checks compliance of CRO delivered ADaM datasets to CDISC standards. Verifies define.xml (for ADaM’s) and ADRG. Develops, validates and documents programs for additional post-hoc analyses. Develops, reviews, documents and performs validation of generic SAS macros, and creates a macro library. Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE). Supports outsourcing programming activities and oversees the QC of these activities. Can assess well time needed for all programming related activities. Is able to independently manage programming activities for 1 or 2 studies and integrated summaries within 1 project simultaneously. Take responsibility to deliver a project in time. Is able to negotiate timelines and can assess when extra resources are needed and is able to communicate this in time. Sr Programmer Analyst (Client Dedicated) - Home based UK/Europe - €/£7,000 Joining Bonus

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our Biostatistics & Programming department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

We are currently recruiting for an experienced Senior Programmer I/II to join PPD, workingdedicated to one of our Biotech clients.Asa Sr Prog you will work directly with the client as part of their team. Supporting the biostatistician and the project team for diverse statistical/programming tasks, and supporting the clinical development programs within the client setting. The tasks mainly focus on programming statistical analysis datasets, outputs and performing the QC thereof. Another major task is ensuring CDSIC compliance of ADaM datasets. In addition to supporting the biostatistician, the Statistical Programmer provides programming support towards Data-Management. Responsibilities include: Provides relevant input in the development of the statistical analysis plan and mock tables, listings and figures. Performs critical review of derived datasets specifications and derived datasets (ADaM). Develops programs to perform QC of statistical outputs. Defines program specific standards for ADaM datasets. Checks compliance of CRO delivered ADaM datasets to CDISC standards. Verifies define.xml (for ADaM’s) and ADRG. Develops, validates and documents programs for additional post-hoc analyses. Develops, reviews, documents and performs validation of generic SAS macros, and creates a macro library. Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE). Supports outsourcing programming activities and oversees the QC of these activities. Can assess well time needed for all programming related activities. Is able to independently manage programming activities for 1 or 2 studies and integrated summaries within 1 project simultaneously. Take responsibility to deliver a project in time. Is able to negotiate timelines and can assess when extra resources are needed and is able to communicate this in time.

Education, Experience and Skills required: Excellent knowledge of SAS is a must. Knowledge in R is a plus. Thorough knowledge of and experience with CDISC standards is desired. Demonstrates ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE). Displays good communication skills and proficiency to work independently and as part of a team. Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development. Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience. Minimum of 5 years of professional experience essential Experience in managing CROs and vendors is a plus. Biotech experience is a plus. Fluent in English

If you have the required skills and experience then please apply, alternatively contact Adam Davis, Senior Recruiter, on adam.davis@ppd.com for more information

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

#LI-AD1

Education, Experience and Skills required: Excellent knowledge of SAS is a must. Knowledge in R is a plus. Thorough knowledge of and experience with CDISC standards is desired. Demonstrates ability to plan and execute the statistical programming tasks for multiple clinical trials and integrated analyses (e.g., ISS, ISE). Displays good communication skills and proficiency to work independently and as part of a team. Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development. Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience. Minimum of 5 years of professional experience essential Experience in managing CROs and vendors is a plus. Biotech experience is a plus. Fluent in English

If you have the required skills and experience then please apply, alternatively contact Adam Davis, Senior Recruiter, on adam.davis@ppd.com for more information

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

#LI-AD1

Job posted: 2021-03-04

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