Work Flexibility: Hybrid

Job Summary

This position is responsible for providing statistical guidance in development
of clinical research programs and of individual studies as part of
multi-disciplinary team. This role involves the development of Statistical
Analysis Plans, encompassing statistical methodology, the definition of derived
variables, formulation of data-handling rules, creation of mockups, and,
ultimately, the analysis of study data to meet business needs.

WHAT YOU NEED:

Essential Duties & Responsibilities:

* Provide timely and scientifically sound statistical expertise to clinical
development projects.Participate in department and cross-functional meetings
to optimize clinical study designs, endpoints, and analysis strategies.

* Collaborate with members of project teams to establish project timelines and
to develop and implement protocolsDevelop statistical analysis plans,
coordinate and perform data analysis and validation as necessary, and provide
data interpretation.

* Provide statistical input to regulatory requests to support and defend




clinical programs.Collaborate with clinical scientists, thought leaders, and
medical writers, both internally and externally, in the publication of study
data.

* Stay current with current developments in statistics, SAS programming, and
regulatory guidance through literature review, conference attendance,
etc.Perform inferential analyses; inputs to the statistical section of the
clinical study report (CSR) and review clinical study report. Provide support
for the study team to move CSR through the review and approval process.
Provide statistical insight into interpretation and discussion of study
results.

* Develop and test SAS programs to generate data sets, tables, listings, and
graphs.Develop and test SAS programs to complete quality control and
validation work on SAS programs, data sets and TLFs generated by
others.Develop SAS programs to create derived variables and data sets (e.g.,
LOCF (Last Observation

📌 Lead Analyst Bio Statistician, Clinical Research (Bengaluru)
🏢 Stryker
📍 Bengaluru