Statistical Programming Department Member
We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What The Statistical Programming Department Does At Worldwide
As an individual on our Biostats and Statistical Programming team, your programming, analytical skills, and ability to process and interpret data are the keys to success. At Worldwide, you'll be able to grow your knowledge of SAS and CDISC standards across all phases of clinical trials. You'll work directly with multiple sponsors, data managers, statisticians, statistical programmers, and the wider study team across a variety of therapeutic areas including cardiovascular, metabolic, neuroscience, oncology & rare diseases. When you work here, you have the autonomy to do your work through hands-on involvement, the support you need to succeed and grow, and the realization that, here, your work really does matter.
What You Will Do
Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL).
Perform review and provide guidance on the development of the clinical database specification, data transfer agreement / specification, specification of tables, figures and listings (TFL) shells.
Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports.
Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study / Analysis Data Reviewer's Guide) for high complexity studies.
Serve as a programming project lead on a complex study (e.g. adaptive design, integrated safety / efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively. Ensure budget and scope of project work remain aligned.
Provide consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements.
What You Will Bring To The Role
The job holder must be computer literate and numerate with a willingness to adapt to various computer systems.
Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.
Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
It is essential that the job holder to possess strong analytical skills and attentiveness to detail.
Educated to degree level or equivalent.
The jobholder has advanced SAS programming skills with expert knowledge in SAS / Macro, Proc Report and ODS. Good working knowledge in SAS / Graph, Proc SQL, SAS / STAT.
Minimum 4 years of previous related experience.
We love knowing that someone is going to have a better life because of the work we do.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Senior Programmer • Worcester, MA, US