Novotech is a leading Asia-Pacific biotech specialist Contract Research Organization (CRO) providing comprehensive clinical development services across multiple phases of clinical trials. With a strong presence in 11 geographies, Novotech has successfully completed over 3,700 clinical projects. The company is committed to excellence, quality, and IT security, holding ISO 27001 and ISO 9001 certifications. Novotech’s global footprint extends to the United States and the UK, making it a preferred partner for biopharmaceutical companies worldwide.
Responsibilities in the Job
As a Statistical Programmer I, the selected candidate will play a crucial role in supporting statistical programming tasks for clinical studies. The key responsibilities include:
- Developing and maintaining Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications for assigned projects.
- Programming SDTMs, ADaMs, tables, figures, and listings (TFLs) based on approved specifications.
- Adhering to company programming standards and data conventions.
- Ensuring that all SAS programs generated for data storage, transformation, presentation, and statistical analysis are well-documented and traceable.
- Maintaining study documentation, programs, and project files in an organized manner.
- Participating in statistical programming section meetings and discussions with the Biostatistics and Biometrics departments.
- Gaining proficiency in statistical programming tools and software.
- Ensuring compliance with regulatory agency guidelines, corporate policies, and Standard Operating Procedures (SOPs).
Qualifications and Experience
To be considered for the Statistical Programmer I position, applicants must meet the following criteria:
- A minimum of a bachelor’s degree in Life Sciences, Computer Science, Mathematics, Statistics, or a related quantitative field.
- Basic knowledge of Base SAS programming.
- Good organizational and communication skills.
- Ability to work independently while maintaining effective professional relationships with co-workers, managers, and clients.
Required Skills
To excel in this role, candidates should possess the following skills:
- Proficiency in SAS programming and statistical analysis techniques.
- Strong problem-solving abilities and analytical thinking.
- Attention to detail in programming and data validation.
- Understanding of clinical trial processes and data management.
- Ability to multi-task and manage deadlines effectively.
