- Develop and maintain SAS programs for statistical analysis, data manipulation, and reporting purposes.
- Implement advanced statistical methodologies and algorithms to analyze complex datasets.
- Responsible for the production and QC of an ISS and ISE package for an oncology submission.
- Write ADaM specifications, programming, QC, and P21 validation for the integrate summary of safety (ISS) and integrated summary of efficacy (ISE) datasets, TFL production, and an e-submission package.
- Collaborate with researchers and analysts to understand project requirements and translate them into technical specifications.
- Perform data cleaning, validation, and quality assurance procedures to ensure data integrity.
- Generate tables, listings, and graphs to summarize analytical results and communicate findings effectively.
- Participate in the design and implementation of statistical analysis plans.
- Contribute to the development and documentation of programming standards, processes, and best practices.
- Stay current with industry trends and advancements in statistical programming techniques and methodologies.
- Provide support and guidance to junior team members, as needed.
- Collaborate with cross-functional teams to deliver high-quality, actionable insights and recommendations.
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or related field.
- 5-8 years of experience in SAS programming language, including SAS/Base, SAS/STAT, SAS/Macro, and SAS/SQL.
- 5-8 years of experience in the production and QC of an ISS and ISE package.
- 5-8 years of experience in writing ADaM specifications, programming, QC'ing, and P21 validation for the integrate summary of safety (ISS) and integrated summary of efficacy (ISE) datasets, TFL production, and e-submission packages
- 5-8 years of experience in solid tumor oncology and submission work
- Strong understanding of statistical concepts and methodologies, such as regression analysis, survival analysis, and Bayesian statistics.
- 5-8 years of experience with data manipulation and analysis techniques, including data merging, transformation, and imputation.
- Excellent problem-solving skills and attention to detail.
- Ability to work effectively in a collaborative, team-oriented environment.
- Effective communication skills, with the ability to explain complex technical concepts to non-technical stakeholders.
- Experience working in a research or healthcare-related field is a plus.
- Familiarity with other statistical software packages (e.g., R, Python) is desirable but not required.
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Sr. Statistical Programmer - Hyderabad, India - K3-Innovations, Inc.
Description
Statistical Programmer (SAS) (Must be flexible with US hours)
Position Overview: We are seeking a skilled Statistical Programmer proficient in SAS to join our team. The successful candidate will play a key role in supporting our research and analysis efforts by developing, implementing, and maintaining statistical programs and algorithms. The Statistical Programmer will collaborate closely with our multidisciplinary team of analysts, statisticians, and researchers to ensure the accuracy and reliability of our data analysis processes.
Responsibilities:
Qualifications: