- Independently translate and implement algorithms and protocols in a high performance computing environment. Apply bioinformatics algorithms and prepare reports of results in a reproducible manner. Provide statistical programming support for multiple clinical projects or therapeutic areas & performance management for statistical programmers.
- Optimize existing pipelines and workflows, as well as help establish new pipelines and workflows. Retrieve and organize complex data types and structures as needed. Responsible for compliance with applicable Corporate and Divisional Policies and procedures
- Ensure internal consistency of output and assess consistency with other activities for the project, as applicable. Leads effort to determine project standards related to output design and statistical programming conventions and independently ensure they are appropriate to support project objectives
- Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards; the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities; determining the scope of the peer review and for ensuring peer review has been completed for all activities for the assigned projects
- Ensure all SAS programs are imported into the archive system prior to the creation of final output; all programs are formally archived after the completion of the regulated activity; clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies
- Develop database checks for routine and non-routine situations. Design and develop various software and systems to effectively generalize programming effort across projects.
- Participate in the development of standard data quality assurance tools
- Responsible for the creation and accuracy of derivation programs for routine and non-routine situations, submission data sets and analysis programs, and data definition documents and TOCs; ensuring peer review has been completed for all derivation programs for assigned projects; monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards for submission data sets & programs.
- Responsible for formulating proposals for new utilities, as well as, presenting information on existing utilities and identifying opportunities for productivity improvements and formulating implementation plans
- Provide accurate and timely responses to routine requests from clients. Guide clients on possible options for deliverables for non-routine requests. Responsible for developing and maintaining good client relationships. Ensures that self and staff are compliant with training requirements. Effectively mentor statistical programming and non-statistical programming peers with regard to functional operations.
- Master’s degree in Computer Science, Bioinformatics, Biostatistics, or related field, with at least 8 years of relevant experience, or Bachelor’s degree with at least 10 years of relevant experience. MS in Statistics, Computer Science or a related field with 8+ years of relevant experience or BS in Statistics, Computer Science or a related field with 10+ years of relevant experience
- High degree of technical competency and strong communication ability, as well as fluency in 2 or more or relevant programming languages, such as R, Python, Perl, Ruby, Java, or C++. Competent in SAS programming and Macro development.
- Demonstrated proficiency in a Linux environment and high performance distributed computing with system administration experience is desired.
- Experience handling and managing data/software associated with high-throughput instruments for genetics and/or genomics. SAS Macros expertise. GPU programming skills. Experience with cloud computing, version control, and Docker or similar technologies
- Experience with SQL or other languages used for managing relational databasesFluency with genomic databases (such as those relating to genome annotation, genetic variants, public data repositories).
- Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience
- Thorough understanding of ICH Guidelines and relevant regulatory requirementsProject lead experience required. Management experience not required. Strong communication skills in a collaborative environment
Significant Work Activities: N/A
Job Type: Experienced