MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
- SAS Programming and Validation of Final Tables, Listings and Figures (TLFs)
- Programming and Validation of SAS domains (CDISC)
- Creation and Validation of Analysis datasets
- Review of Annotated Case Report Form (aCRF)
- Review of Edit Checks (DVP) document.
- Extraction of Datasets from various databases to create SAS datasets
- Preparation and Review of Mapping specifications for creating domain datasets - CDISC
- Any other responsibilities assigned by the Director - Biostatistics as and when need arises
- Maintain 100% Quality and on time delivery of above activities
KEY RESULT AREAS
- Acquire up to date information about statistical software updates and knowledge of statistical methods and techniques in SAS programming. Get trained in current data standards, templates and guidelines in regulatory submissions. Develop SAS applications using higher-level features. Periodically updating CDISC skills through guidelines. It is expected that the post holder will perform duties without direct supervision and will be self directed in terms of time and workload management.
- Minimum 4-12 years of practical experience in Pharmaceutical industry or CRO is desirable
- Experience includes good programming knowledge in SAS, knowledge on MS Access and Excel, SQL and Oracle Clinical
- Experience in regulatory submission is desirable
- Excellent knowledge in Clinical Trials and regulatory activities
- Excellent knowledge in ICH, GCP, 21 CFR etc.
- Leadership & Management
- Excellent Leadership skills and ready to work in a team
- Maintain good harmony and coordination among team members
- Take lead role to complete the programming activities for the assigned studies
- B. Tech / MCA / M. Sc in Statistics, Mathematics or Computer Science
- Excellent knowledge in SAS programming
- Interest in SAS Programming, statistical methods, clinical research, drug development and CDISC activities.
- Strong desire to learn new techniques in SAS and statistics.