Job description
- The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products.
- The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity.
- The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.
- Leads the statistical programming activities for projects with lower complexity.
- Leads the statistical programming activities for studies.
- Develop SAS programs for the creation of ADaM data sets following
CDISC standards. - Develop SAS programs for the creation of Tables, Listings and Figures.
- Validation of ADaM data sets, Tables, Listings and Figures.
- Create specifications for the structure of ADaM data sets for individual studies and integrated data.
- Create documentation for regulatory filings including reviewers guides and data definition documents.
- Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
- Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.
- MS in Statistics, Computer Science, or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
- In-depth understanding of SAS programming concepts and techniques related to drug development.
- Fundamental understanding of CDISC Standards.
- Fundamental understanding of the drug development process, including experience with regulatory filings.
- Ability to communicate clearly both oral and written.
- Ability to accurately estimate effort required for study related programming activities.
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Frequently asked questions
Q: What skills or qualities help someone succeed as a Senior Statistical Programmer?
A: To succeed as a Senior Statistical Programmer, key technical skills include proficiency in programming languages such as R, Python, or SAS, as well as expertise in statistical software like SAS, SPSS, or R Studio. Additionally, strong analytical and problem-solving skills, along with the ability to communicate complex statistical concepts to non-technical stakeholders, are essential. A combination of these technical and soft skills enables Senior Statistical Programmers to effectively design, implement, and interpret statistical models, ultimately driving data-driven decision-making and career growth in the field.
Q: What is the career path for a Senior Statistical Programmer?
A: A Senior Statistical Programmer's career path typically begins with entry-level roles such as Statistical Programmer or Biostatistician, progressing to mid-level positions like Senior Statistical Programmer or Lead Programmer, and eventually reaching senior roles like Principal Statistical Programmer or Director of Biostatistics. Key opportunities for skill development and growth include mastering programming languages like R, SAS, or Python, learning statistical software like SQL or data visualization tools like Tableau, and developing leadership and communication skills to manage teams and collaborate with stakeholders. Long-term career prospects may lead to roles in data science, biometrics, or regulatory affairs, or even transition into leadership positions like Department Head or Director of Data Science.
