Job Overview: We are seeking a dedicated Senior Statistical Programmer to join our dynamic team. You will be responsible for the development, quality control, and documentation of statistical (SAS) programming deliverables for clinical research studies.
Key Responsibilities:
1. Lead and oversee the development of SAS programs for the management and statistical analysis of clinical trial data.
2. Develop, test, and validate statistical tables, listings, and graphs (TLGs) in support of the statistical analysis plan.
3. Support the generation and review of protocols, data management plans, study reports, and other regulatory documents.
4. Provide input to the statistical analysis plan, table shells, data integration plans, and mock-ups.
5. Ensure data quality by designing and validating key data checks and listings.
6. Develop specifications for derived datasets and perform data transformation as necessary.
7. Collaborate effectively with data management and biostatistics teams, clinicians, and other project stakeholders.
8. Guide junior programmers and provide mentoring as needed.
9. Keep abreast of new developments in SAS programming and clinical research, and act as a subject matter expert for the team.
Required Qualifications and Skills:
1. Bachelor's or master’s degree in Statistics, Mathematics, Computer Science, or a related field.
2. Minimum of 3 plus years of statistical programming experience in the pharmaceutical, biotech, or CRO industry.
3. Excellent SAS programming skills and proficiency in SAS/Base, SAS/Macro, SAS/Graph, and SAS/STAT.
4. Familiarity with CDISC SDTM and ADaM data standards.
5. In-depth understanding of clinical trial data and extremely complex statistical methods.
6. Excellent problem-solving skills and a proactive approach to identifying and resolving issues.
7. Strong written and verbal communication skills, with the ability to translate complex data into understandable results.
8. Proficiency in English, with excellent written and verbal communication skills.
9. Prior experience leading teams or projects is highly desirable.
Preferred Skills:
1. Experience in oncology, immunology, respiratory, infectious diseases, or neurosciences is a plus.
2. Knowledge of other statistical software such as R or Python is a plus.
3. Knowledge of regulatory guidelines (FDA/EMA/ICH) is preferred.
Shubham Vishwakarma
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