06 Sep
|
Jobgether
|
India
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Biostatistics based in India.
This is a senior biostatistics opportunity within global clinical development, supporting the design, execution, analysis, and interpretation of registration-directed clinical trials. You will serve as a study biostatistician across development programs and multiple studies, contributing statistical expertise throughout the clinical development lifecycle. The role combines hands-on statistical analysis with strategic input into study design, regulatory submissions, and cross-functional decision-making. You will collaborate with clinical development teams and external partners while ensuring high-quality deliverables and alignment with regulatory requirements and established procedures. The position also offers the opportunity to contribute to statistical methodology innovation, trial design simulations, process improvements, and the development of technical standards. Success requires strong technical expertise,
independent judgment, attention to detail, and the ability to manage multiple priorities in a rapidly evolving workplace. This remote/hybrid role is well suited to a motivated biostatistics leader who wants to make a meaningful impact on global clinical programs.
Accountabilities:
- Study Biostatistics: Serve as the study biostatistician across development programs and multiple clinical studies, providing statistical expertise throughout the study lifecycle.
- Statistical Documentation: Author Statistical Analysis Plans (SAPs), TFL shells, and other study-related statistical documents, ensuring they are scientifically sound, accurate, and delivered according to established timelines.
- ADaM & TFL Oversight: Review ADaM specifications, oversee the generation of ADaMs and Tables, Figures, and Listings (TFLs), and ensure timely, high-quality statistical deliverables.
- Statistical Ana
📌 Senior Manager, Biostatistics (India)
🏢 Jobgether
📍 India