Principal Statistical Programmer at Roche in Pleasanton, CA
Principal Statistical Programmer/Manager will be responsible for end to end macro development for supporting statistical programming activities for registrational and non-registrational studies. Strong technical competence and ability to incorporate statistical concepts and approaches into practice are required. Contribute to efficiency initiatives around process, people and tools and streamline data standardization. Participates as part of a study team in some cases and contributes towards developing, validating, and documenting programs written using SAS software to manage the project deliverables. Essential Functions oFunctions as the primary point of contact for programming related tasks for assigned study. Develops SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency. oExperience in creating submission documents in diagnostics/devices necessary to support submissions to regulatory agencies in electronic format a plus. Experience in FDA submissions / IVDR submission a plus. oMentors lead programmers for creating data specifications to generate source and analysis datasets as per the study requirements. oHelp with creation of end-to-end standard macro driven tools that increase the efficiency of the programming function. oValidate and maintain global tool library such as SAS macros. oWork with sub chapter lead to simplify / scale the validation process based on risk. oInterface with internal and external study teams to provide technical support. oParticipate in the development and/or maintenance of departmental procedures and standards. oAssist in providing new employee orientation, training, and mentorship
Qualifications Education:
Minimum:
Under graduate in Computer Science, Engineering or any other quantitative area of discipline. Preferred:
Master's degree in in Computer Science, Engineering or any other quantitative area of discipline.
Experience:
Minimum:
10 years of experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics or medical device environment. Preferred:
13 or more years of experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics or medical device environment. Knowledge, Skills and Abilities:
oMust have strong technical competence and knowledge of Base SAS, SAS/STAT, SAS macros, and SAS/GRAPH. oFamiliarity with other statistical software, statistical analyses and databases. oStrong verbal and written communication skills.
Salary Range:
$150K -- $200K
Minimum Qualification
Data Science & Machine LearningEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications Education:
Minimum:
Under graduate in Computer Science, Engineering or any other quantitative area of discipline. Preferred:
Master's degree in in Computer Science, Engineering or any other quantitative area of discipline.
Experience:
Minimum:
10 years of experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics or medical device environment. Preferred:
13 or more years of experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics or medical device environment. Knowledge, Skills and Abilities:
oMust have strong technical competence and knowledge of Base SAS, SAS/STAT, SAS macros, and SAS/GRAPH. oFamiliarity with other statistical software, statistical analyses and databases. oStrong verbal and written communication skills.
Salary Range:
$150K -- $200K
Minimum Qualification
Data Science & Machine LearningEstimated Salary: $20 to $28 per hour based on qualifications.
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