About this role
The team is seeking a skilled Statistical Programmer to join their team in India. The successful candidate will be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as the specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and Tables, Listings, and Figures (TLFs). This role is crucial for various purposes, including Data Monitoring Committee (DMC) data review meetings and Interim Analyses (IAs).
Key Responsibilities:
- Develop and validate annotated Case Report Forms (aCRFs).
- Create specifications for SDTM and ADaM datasets.
- Program and validate Tables, Listings, and Figures (TLFs).
- Ensure compliance with regulatory standards and guidelines.
- Collaborate with cross-functional teams to support data analysis and reporting.
- Participate in data review meetings and provide statistical insights.
Required Skills & Qualifications:
- Proficiency in statistical programming languages such as SAS or R.
- Experience with clinical trial data and regulatory submissions.
- Strong understanding of SDTM and ADaM standards.
- Ability to work independently and manage multiple projects.
- Excellent communication and teamwork skills.
Experience:
- A minimum of 3-5 years of relevant experience in statistical programming within the pharmaceutical or clinical research industry.
What we offer:
- An opportunity to work in a dynamic and innovative environment.
- Professional development and career growth opportunities.
- A collaborative team culture focused on excellence.
Applications are read by our talent team, usually within two working days.
If you look like a fit we will call you, and you will hear from us either way.