Contribute to the development and review of SDTM and ADaM datasets and specifications.
Support the preparation and review of Define-XML and other clinical trial documentation.
Work closely with Senior Statistical Programmers, Biostatisticians, Data Managers, and other cross-functional team members.
Electronic Submissions
Support the programming and validation of CDISC-compliant datasets and deliverables for regulatory submissions.
Assist with the preparation of supporting documentation for electronic submissions.
Ensure programming outputs follow applicable standards, specifications, and quality requirements.
Quality and Validation
Perform programming validation and quality checks according to established procedures.
Identify, document, and resolve programming issues in collaboration with senior team members.
Ensure assigned deliverables are completed accurately and within agreed timelines.
Standards and Guidelines
Follow departmental programming standards, working instructions, and applicable industry guidelines.
Develop knowledge of CDISC standards, including SDTM and ADaM.
Assist in maintaining and improving programming macros, utilities, and reusable functions.
Qualification & Experience
Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Engineering, Life Sciences, or a related discipline.
0–2 years of experience in statistical programming, preferably within the pharmaceutical, biotechnology, CRO, or clinical research industry.
Basic to intermediate knowledge of SAS and/or R.
Familiarity with SAS programming and SAS Macro language is preferred.
Basic understanding of clinical trial data and the drug development process.
Knowledge or exposure to CDISC standards, SDTM, and ADaM is preferred.
Familiarity with clinical trial datasets, tables, figures, and listings is an advantage.
Strong attention to detail and commitment to data quality.
Ability to work effectively in a team environment and learn from senior team members.
Ability to manage assigned tasks and meet project timelines.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-DNP
