Job Description

　　We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - 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 the organisation provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight.

　　As a Senior/Principal Programmer with FSP, you will act as the lead programmer, project lead, or project oversight lead, dedicated to one client and overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting.

　　Your responsibilities will include (but are not limited to) the following:

　　Acts as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets. Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs. Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS. Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits. Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry. Provides training, guidance, and project leadership to junior team members. Provides general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs. Provides input into bidding process as requested.

　　Qualifications - External

　　Education and Experience:

　　Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 8 years' experience in hands-on programming, with lead programming experience.

　　OR

　　Bachelor's degree in a related discipline and at least 10 years' experience in hands-on programming, with lead programmer experience.

　　Knowledge, Skills and Abilities:

　　In-depth understanding of one or more programming languages. SAS required.ADaM, TLF programming, DMC support and regulatory support experience.Proven experience as an independent, lead programmer.Experience programming complex analysis datasets and outputs (efficacy, complex lab and regulatory requests)eCRT and define.xml knowledgeStrong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language Demonstrated leadership ability and ability to work on a multi-disciplinary project team, training and mentoring othersSolid project management skills to act as project lead across the most challenging and complex projects.Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

　　At PPD clinical research services 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 clinical research services 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 we 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.

　　Our 4i Values:

　　Integrity - Innovation - Intensity - Involvement

　　If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!