Statistical Analyst IIKatalyst Healthcares & Life Sciences • Worcester, MA, United States
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Statistical Analyst II
Katalyst Healthcares & Life Sciences • Worcester, MA, United States
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]MS in Statistics, Computer Science or a related field with 5 to 7 years of SAS programming experience in Pharmaceutical or related industry OR. BS in Statistics, Computer Science or a related field with 5 to 7 years of SAS programming experience in Pharmaceutical or related industry. Strong experience with clinical trials, including familiarity with expectations of regulatory agencies, Strong working experience / skill in ADaM datasets creation / validation. Strong technical and communication skills, both oral and written. Competent in SAS programming, macro, and utilities development. Good CDSIC knowledge. Provide accurate and timely responses to requests from clients with a sense of urgency. Be compliant with training requirements.
Responsibilities :
- Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to solve problems related to non-routine situations.
- Responsible for the creation and validation of ADaM, TLFs for CSR, ISS, and Client following's SOPs, department, and project standards.
- Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and resolving Pinnacle 21 checks.
- Responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan.
- Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
- Ensure consistency across studies within a project.
- Responsible for the creation of data definition documents, TOCs, and support submission related activities.
- Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers.
- Develop new macros and utilities.
Requirements :
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