PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
We 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.
DTS Department responsibilities include specification, development, quality validation and regulatory submission compliance adherence for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables. In addition deploys Spotfire dashboards, Safety notification and reporting for Medical Monitor review and regulatory actions. Acts as a key team member for internal Biostat interactions and client engagement on CDISC submission topics, or internal contact for procedural and technical initiatives. Ensures effective delivery across all project requirements including communicating priorities and work direction to complete assigned tasks on time and within budget. Participates in client and department wide engagement on CDISC solutions, integrations and submissions.
Performs bioinformatics programming activities for the statistical and computational considerations of research projects. Serves on a study team under the direction of a lead programmer.
Performs programming tasks as assigned by study project team leads that includes but is not limited to independently creating, executing, maintaining, and validating programs that transfer data across multiple data management systems or operating systems, combining data from a variety of sources and structures, generating and storing summary data from a variety of sources, generating reports or combining multiple databases and validating programs that generate listings, tables and figures using SAS and standard tools and processes.
Prepares and analyzes clinical trial patient datasets, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes. Consults with researchers and multi-disciplinary project teams to analyze problems and recommend technology-based solutions and computational strategies for the specific project as assigned.
Develops the customized codes to utilize existing tools and applications to provide the outputs or to validate outputs for clinical bioinformatics or technical use.
Functions as a contributing member of a multidisciplinary team, and under the oversight and review of management, may begin to assist with some lead programming activities. Ensures adherence to departmental working practice documents and SOPs, and contributes to informal training materials.
Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.
Education and Experience:
MS/MA degree in computer science, statistics, biostatistics, mathematics or related field, and abilities to perform the job, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 2 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Solid understanding of one or more programming languages
Good attention to detail
Satisfactory problem-solving skills
Satisfactory written and verbal communications skills, including proficiency in the English language
Capable of effectively organizing and managing multiple assignments with challenging timelines
Positive attitude and capable of working well with others
Demonstrated initiative and motivation
Solid understanding of relational data base structure and complex data systems Good organizational skills and capable of adapting and adjusting to changing priorities
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
PPD Defining Principles:
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!
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.