Principal Biostatistician

2 weeks ago

Bengaluru, India Novotech Asia Full time

**Principal** **Biostatisticians**

Minimum Qualifications & Experience:
Masters or PhD with a major is statistics/biostatistics or related field with > 10 years of pharmaceutical industry, CRO or related experience. Proficiency with Microsoft Office tools (Word and Excel) and standard statistical packages (SAS TM) is expected.

**Responsibilities**:
1.Perform or supervise complex statistical analyses and create or provide input to statistical reports. 2.Cooperate with other company departments to optimize the global efficiency.

3.Act as a pro-active advisor for all types of analysis during the proposal process as well as during the project life cycle.

4.Define strategies and evaluate the statistical resources needed to meet the defined project goals. 5.Coordinate Biostatistics related project activities for successful completion within given timelines and budget.

6.Interact with internal and external clients with regard to data analysis, scope of work, and budget. 7.Ensure compliance with applicable regulatory agency guidelines and Novotech SOPs in study design, protocol development and all other statistical output.

8.Perform protocol development, sample size calculation, protocol and CRF review.

9. Write statistical sections of integrated reports.

10.Review derived datasets and all types of statistical analysis deliverables.

11.Develop complex analysis strategies and execute them using efficient programming techniques. 12.Produce and provide expert input to analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.

13.Quality control of all kinds of statistical deliverables.

14.Training/mentoring of junior members of the department.

15.Representing Novotech at client meetings.

16.Participation in industry forum (conferences, professional association committee work etc.) as a means of professional development as well as promotion of Novotech's image in industry.

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