Key Skills: Sr. Biostatistician, biostatistics, SAS, CDM

Job Overview:

The Senior Biostatistician is responsible for statistical methodology and statistical analysis plans for clinical studies. The Senior Biostatistician must ensure that activities and processes performed are conducted according to company and sponsor requirements. This position works closely with other Project Team members. Act as lead Statistician on complex trials and across multiple studies. This position requires time and resource management skills, and strong statistical expertise. Computer proficiency is required. This position must be able to work without close supervision and may coordinate the activities of other staff members

Responsibilities:

Act as a lead representative of the Biostatistics department on project teams. Attend project team meetings as necessary

Act as Biostatistics contact with Sponsor to address statistical issues, manage client expectations, note and respond to out-of-scope work

Some business development work may be required, such as input to proposals and client presentations

Write statistical methodology sections of individual protocols. Write formal Statistical Analysis Plans to be carried out in the analysis of clinical studies

Perform statistical analyses of data and interpret results to ensure validity of conclusions

Interact with Data Management personnel as necessary to ensure that datasets are in usable format; perform statistical diagnostics prior to database locking

Ensure that appropriate programs are developed for current clinical studies

Perform statistical quality control review for each project

Interact with Medical Writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information. Review draft documents

Interact with other departments, such as Clinical Operations and Project Management, to ensure a high level of client satisfaction through successful execution of projects
Salary:

INR 10,00,000 - 20,00,000 P.A
Industry:

Pharma, Biotechnology, Clinical Research
Functional Area:

Healthcare, Medical, R&D
Role Category:

R&D
Role:

Bio-Statistician
Keyskills:

biostatistics, SAS, CDM
Desired Candidate Profile
Education:

(UG - Any Graduate - Any Specialization) AND (PG - Any PG Course - Any Specialization, Post Graduation Not Required)

M.S. degree in Statistics

Computer proficiency is required

Proficient in the use of SAS

Demonstrated ability to perform statistical analyses of all phases of clinical trials data

Ability to read, analyze, and interpret common scientific and technical journals

Thorough knowledge of applicable regulatory rules and guidelines, e.g. ICH Guidelines

It is a global product development services provider with the full-spectrum operational and therapeutic expertise to help pharmaceutical, biotechnology, and medical device companies improve patient carefaster and more efficiently, with less risk and expense