Senior/Principal Statistical Analyst (Senior/Principal Statistical Programmer)
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location. Senior/Principal Statistical Analyst The primary function of this role is to provide statistical programming support for multiple clinical projects or therapeutic areas. Will collaborate primarily with other statistical programmers, statisticians, and data managers, as well as with clinical teams, to achieve study and project goals. Will coordinate the statistical programming activities for multiple clinical projects. Key responsibilities include:
- 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.
- Contribute to the determination of project standards related to output design and statistical programming conventions and independently ensure they are appropriate to support project objectives.
- Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities. Responsible for 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. Ensure all programs are formally archived after the completion of the regulated activity.
- Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies. Review for consistency across studies within a project. Assist with developing CRF and database standards for the assigned projects.
- Ensure accuracy of database quality assurance checks and assess data accuracy and consistency. Develop database checks for routine and non-routine situations.
- Responsible for the creation and accuracy of derivation programs for routine and non-routine situations. Responsible for ensuring peer review has been completed for all derivation programs for assigned projects.
- Responsible for the creation and accuracy of submission data sets and analysis programs for routine and non-routine situations. Responsible for the creation of data definition documents and TOCs. Responsible for ensuring peer review for all submission data sets and programs for the assigned projects.
- Maintain expertise in the use of the UNIX utilities. Independently develop new UNIX utilities. Responsible for formulating proposals for new utilities, as well as, presenting information on existing utilities.
- Responsible for identifying opportunities for productivity improvements and formulating implementation plans. Independently develop new processes.
- Maintain expertise in the use of the SAS Macros. Independently develop new SAS Macros. Responsible for formulating proposals for SAS Macros, as well as, presenting information on existing Macros.
- Represents the Statistical Programming Organization on Study Teams and be adhoc participant on PST teams.
- 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
- High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development. 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.
- Demonstrated extended understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Demonstrated ability to apply SAS programming knowledge to solve problems related to non-routine situations.
- Demonstrated proven ability to interpret statistical analysis plans to develop analysis data set specifications.