Role: Lead statistical Analyst /Lead Statistical Programmer/Manager, Statistical Programming
Required Skillsets:
- Experience in leading a team of statistical programmers for a compound/indication or therapeutic area
- Proficiency in SAS / R programming languages to Program and validate ADaM , TFL and statistical analyses
- In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle
- Good to have experience in other statistical programming languages (R).
- In-depth understanding of CDISC standards and therapeutic area (Oncology, Immunology , Neuroscience Etc.)
- Experience with regulatory filings.
- Effective communication skills (both written and verbal)
- Ability to effectively represent the Statistical Programming Organization in cross functional teams (Statisticians, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations).
- Ability to accurately estimate effort required for project related programming activities.
- Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines
Key Responsibilities:
1. Leads the statistical programming activities for a compound/inidication.
2. Leads a team of statistical programmers and manages the resource planning for assigned staff.
3. Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
