Statistical Programmer

Key Skills

Python Programming, Scala Programming, C++, Java Programming, Machine learning techniques, Data science techniques, SQL, Apache Hadoop, MapReduce, TensorFlow, PyTorch, R Programming, Statistics, Biostatistics

Job Description

The position is responsible for providing support to Japan clinical development projects statistical sciences/programming. This support is supplied in the context of a cooperative, project-oriented effort and included data capabilities in general planning and execution of clinical trials, statistical analysis and reporting of the data from these trials, and regulatory submissions and inspections.

• Perform statistical analysis as per the analysis plan. Collaborate with Statistical Sciences/Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
• Develop strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Partner with Data Science in preparing for database lock.
• Responsible for the creation and accuracy of derivation programs, including peer review.
• Responsible for the creation and accuracy of submission data sets and analysis programs. Responsible for the creation of data definition documents.
• Support for dealing with the authorities. Perform follow-up and analysis of clinical study data, based on requirements and comments from PMDA, and support preparation of response.

Qualifications

• At least 5 years of experience in pharmaceutical R&D including at least 3 years’ experience in Statistical Sciences/Programming areas.
• A bachelor’s degree in or equivalent knowledge of statistics/mathematics, pharmacy, biology, pharmacology or related scientific field focused on quantitative skills. A master’s or doctor’s degree is more favorable.
• Proficient in English communication skills (TOEIC 650 or more or equivalent)
• Good leadership skills as defined by AbbVie core leadership behaviors.

The following experiences and knowledges are preferred.

• CDISC and e-data submission
• Unix-SAS
• Statistics for clinical development
• Work with global