Clinical Programmer III

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. 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. Together, we are striving to outsmart cancer.

General Position Summary/Purpose:

Provide clinical programming support to produce deliverables for data conversion, data comparison, data cleaning, data review and monitoring activities. Support multiple clinical projects or therapeutic areas by ensuring internal consistency of data/outputs and assess consistency with other activities for the project as applicable while also ensuring database quality assurance checks and assess data for accuracy and consistency.

Key Accountabilities/Core Job Responsibilities:

• Independently program and implement algorithms in a high performance computing environment to create SAS datasets, intermediate lab datasets, data listings, delta listings, edit checks, study metrics reports, data reconciliation report and other ad-hoc reports.
• Participate in EDC study design and develop database checks for routine and non-routine situations.
• Apply MedDRA/WHO Drug coding to the raw datasets.
• Develop SAS programs to generate MedDRA/WHO Drug dictionary coding fiiles and coded datasets.
• Create and/or Validate intermediate lab datasets and Apply NCI CTC Toxicity grades; communicate findings to Lab data managers.
• Communicate an understanding of clinical programming concepts, basic clinical principles and act in accordance with those principles.
• Communicate data issues and effectively mentor non-clinical programming peers with regard to clinical programming practices and mentor statistical programming/non-statistical programming peers with regard to functional operations.
• Work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission.
• Ensure that appropriate programs are formally archived after the completion of the regulated activity.
• Ensure clarity, accuracy and consistency of case report forms (CRFs) and database definitions for individual studies.
• Review for consistency across studies within a project; contribute with developing project conventions and verifying that conventions are followed.
• Provide accurate and timely responses to routine and non-routine requests from clients.
• Contribute to the development of new SAS- and Windows-based utilities; responsible for formulating proposals for new utilities, as well as presenting information on existing utilities.
• Develop database checks for routine and non-routine situations.
• Ensure accuracy of database quality assurance checks and assess data accuracy and consistency.
• Contribute to the development of new SAS Macros; responsible for formulating proposals for SAS Macros as well as presenting information on existing Macros.
• Assist in the development of new processes and provide accurate and timely responses to routine requests from clients and guide clients on possible options for deliverables for non-routine requests.
• Be compliant with training requirements; effectively mentor Clinical Programming peers and junior programmers with regard to functional operations.
• Coordinate the Clinical Programming activities for 0-4 clinical projects within the same therapeutic area.
• Oversee the work of junior Clinical Programmers or contractors.

Qualifications:

• High degree of technical competence and communication ability, both oral and written.
• Competent in SAS including SAS Macro programming and application development.
• Pharmaceutical or related industry experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Demonstrated practical understanding of SAS programming concepts and techniques appropriate to pharmaceutical industry.
• Demonstrated satisfactory ability to apply SAS programming knowledge to solve problems related to non-routine situations.
• Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
• Expertise in the use of SAS Macros.
• Ability to work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission.
• Ability to appropriately delegate assignments and review deliverables so that projects are delivered on time with suitable quality.
• Ability to identify opportunities for productivity improvements and formulate implementation plans.
• Ability to contribute to the determination of project standards related to output design and statistical programming conventions, and, with supervision ensures they are appropriate to support project objectives.

Education and Experience:

• MS in Statistics, Computer Science or a related field with 5+ years of relevant experience; OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled