Job Summary
We are seeking a Senior Biostatistician to act as a study/lead biostatistician supporting clinical trials. The ideal candidate will have a strong technical foundation, excellent problem-solving skills, and the ability to collaborate effectively across multidisciplinary teams.
Key Responsibilities
- Serve as the lead biostatistician for clinical trials, ensuring statistical rigor and quality.
- Develop and review Statistical Analysis Plans (SAPs) and table shells.
- Oversee the data flow process from raw data through SDTM, ADaM, and TLF development.
- Utilize SAS and LSAF systems for data analysis and programming tasks.
- Demonstrate an aptitude for learning and applying additional programming languages such as R and EAST.
- Collaborate with cross-functional teams, including clinical, regulatory, and data management groups.
Qualifications
- Degree in Biostatistics, Statistics, or a related field.
- 5-10 years of experience in biostatistics within a clinical trial setting.
- Proficiency with SAS and LSAF systems is required.
- Familiarity with statistical programming languages such as R and EAST.
- Strong knowledge of CDISC standards (SDTM, ADaM) and clinical data flow.
- Experience in developing SAPs and TLFs.