Senior Clinical Programmer

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 programming support to produce clinical programming deliverables for data conversion, data comparison, data cleaning, data standardization, data review and monitoring activities on all PCYC drugs. Review program codes and suggest alternative solutions that may be efficient. Interact with clinical data managers, statistical programmers, clinical operations, and biostatisticians. For People Manager: Train new programmers, teach efficient programming techniques and guide the programmers in need of assistance. Manage clinical programmers.

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.
• Provide clinical programming support for multiple clinical projects or therapeutic areas.
• Optimize existing workflows, as well as establish new workflows.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Maintain MedDRA and WHO Drug dictionary repository, upversion repository and provide SMQ's.
• Develop and verify SAS programs to generate MedDRA/Who Drug dictionary coding files and coded datasets; maintain Lab Dictionary.
• Independently create and/or Validate intermediate lab datasets and apply NCI CTC Toxicity grades; communicate findings to Lab Data Managers, sdtm programmers and study programmers and resolve issues.
• Ensure internal consistency of output and assess consistency with other activities for the project, as applicable.
• Lead effort to determine project standards related to output design and statistical programming conventions and independently ensure they are appropriate to support project objectives.
• 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.
• Monitor and stay current with regulatory guidelines relevant for the Clinical Programming function.
• Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities; determining the scope of peer review and for ensuring peer review has been completed for all activities for the assigned projects.
• 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.
• Responsible for identifying opportunities for productivity improvements and formulating proposals for new SAS utilities/macros and their implementation.
• Contribute to design, program and deployment of SAS Macros/Utilities to automate programming tasks.
• Apply Blinding and bias controls to Blinded studies.
• Serve as SME advising Biometrics leadership on promoting data quality through various software technologies, programming tools and techniques, data standards, as well as process improvement in support of clinical data cleaning, review and monitoring activities.
• Contribute 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.
• Able to work and manage Clinical Programming activities for multiple clinical projects across therapeutic areas.
• Communicate effectively with all stakeholders.
• For People Manager:
• Performance management for Clinical Programmers.

Qualifications:

• High degree of technical competence and communication ability, both oral and written.
• Competent in SAS including SAS Macro programming, SQL, XML, HTML and application development.
• Demonstrated ability to debug SAS programs.
• Pharmaceutical or related industry experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Thorough understanding of ICH Guidelines and relevant regulatory requirement.
• Project lead experience required.
• Strong communication skills in a collaborative environment.
• Understand CDISC standards and applicability to clinical database design/capture and reporting.
• For People Manager: 5+ years of supervisory experience preferred.

Education and Experience:

• MS in Statistics, Bioinformatics, Computer Science or a related field with 8+ years of pharmaceutical industry work experience; OR BS with 10+ years of relevant experience.

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Equal Opportunity Employer Minorities/Women/Veterans/Disabled