We are currently seeking an experienced Senior Statistical Programmer to join a leading pharmaceutical/biotechnology organisation. This is an exciting opportunity for a highly skilled programmer to support clinical studies and regulatory submissions while working within a collaborative, fast-paced environment.
Key Responsibilities
- Provide statistical programming support across clinical studies and regulatory submissions.
- Develop, maintain, and validate CDISC-compliant SDTM and ADaM datasets .
- Produce and validate Tables, Figures, and Listings (TFLs) for clinical studies, publications, and ad-hoc analyses.
- Create dataset specifications in accordance with SDTM IG , ADaM IG , and Statistical Analysis Plans (SAPs).
- Design, develop, test, and implement programming solutions to meet complex business requirements.
- Develop, maintain, and enhance SAS macros and other programming utilities.
- Perform ad-hoc, exploratory, and validation analyses as required.
- Collaborate effectively with cross-functional teams, stakeholders, and study teams.
- Manage multiple projects simultaneously while delivering high-quality work within strict timelines.
Required Skills & Experience
- Proven experience within the pharmaceutical, biotechnology, or related life sciences industry .
- Advanced SAS programming expertise.
- Hands-on experience with CDISC standards , including SDTM and ADaM .
- Experience producing and validating clinical study datasets and outputs.
- Excellent verbal and written communication skills.
- Strong problem-solving abilities and attention to detail.
- Ability to work independently while contributing effectively within a team environment.
- Previous regulatory submission experience.
- Experience with additional programming languages such as Python, VBA, C++, or similar .
- Experience working within project-based contract environments.
Education
- Bachelor's degree in Mathematics, Statistics, Computer Science , or a related field.
Senior Statistical Programmer in nj at Unknown Company
This position is listed as contract and onsite.