Biostatistician - Clinical Research - Pharma

- Help develop funding applications and research protocols

- Contribute to the proposal and budget development

- Perform sample size/power calculations

- Author statistical analysis plans

- Prepare derived datasets for the analyses using SAS

- Program and validate statistical analyses in SAS

- Perform complex statistical analyses

- Prepare and deliver reports for interim and final analyses

- Contribute to the interpretation and publication of research results

- Independently manage all statistical aspects of a project

- Coordinate a project team of biostatisticians and/or (statistical), programmers

- Provide statistical advice to Institute researchers

- Develop internal capacity in biostatistics via short courses and seminars

- Supervise Master and Ph.D. students

- Keep abreast of new statistical methods

- Actively develop professional networks with peer statisticians locally and internationally

- Comply with all institute policies and SOPs as well as regulatory requirements for the programming, analysis, and reporting of research projects (e.g. FDA, EMEA, TGA, etc)

Requirements:

1. Experience of 36 - 60 months as Analytics / Business Intelligence / Data Science

2. Should create a statistical analysis plan and TFL Shells.

3. Should create and review the programming specification including SDTM/ADAM and TFL.

4. Should have the basic SAS programming skills.

5. At least 2-3 years- experience(Phase 2) in statistics as a statistician.

6. Excellent English skills

7. Notice period should be less than 30 days

About the company:

Dedicated to transforming and presenting data into client-centric outputs that are in sync with your- - drug development needs.-

It is the leading CRO for data analysis in neurological disease including Amyotrophic Lateral Sclerosis (ALS) and Spinal Cord Injury (SCI) and has helped its clients to further their drug development programs. In addition to Neurology, we also have expertise in the therapeutic areas of cardiovascular disease, oncology, vaccines, respiratory, GI, and pediatric studies. Our team is a blend of professionals of doctors, pharmacy graduates, medical writers, statisticians, and programmers with experience in analyzing and reporting Phase 1 to 4 clinical trials compliant with local and international regulatory standards.

Awarded with the Lily Global Supplier Award 2016.