Statistical Programmer I

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.

Statistical Programmer I Job Description

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.

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 statistical programming support for multiple clinical projects or therapeutic areas by ensuring internal consistency of output. Assess consistency with other activities for the project as applicable while also ensuring accuracy of database quality assurance checks and assess data accuracy and consistency.

Key Accountabilities/Core Job Responsibilities:

• Provide support in developing of SAS programs to generate and creation of tables, listings, graphs, and narrative for routine situations and with supervision for non-routine situations.
• Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies.
• Accountable for providing Statistical Programming support for clinical trials by collaborating primarily with other statistical programmers, statisticians, and data managers, as well as with clinical teams, to achieve study and project goals.
• Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles.
• Effectively mentor non-statistical programming peers with regard to statistical 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 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.
• Review for consistency across studies within a project; assist with developing project conventions and verifying that conventions are followed.
• Assist with developing project conventions and verifying that conventions are followed.
• Provide accurate and timely responses to routine requests from clients and with supervision responses to non-routine requests from clients.
• Develop database checks for routine situations and with supervision develop checks for non-routine situations.
• Ensure accuracy of database quality assurance checks and assess data accuracy and consistency.
• Responsible for the creation and accuracy of derivation programs for routine situations, including peer review and with supervision create derivation programs for 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 situations and with supervision for non-routine situations.
• Responsible for the creation of data definition documents and TOCs and for ensuring peer review for all submission data sets and programs for the assigned projects.
• Participate in the development of new SAS Macros; responsible for formulating proposals for SAS Macros as well as presenting information on existing Macros.
• Participate 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 statistical programming peers with regard to functional operations.
• Coordinate the statistical programming activities for 0-3 clinical projects within the same therapeutic area.
• Oversee the work of 0-3 Statistical Programmers/Senior Statistical Programmers or contractors.
• Provide support of developing R statistical programs in creating data visualization dashboards with advanced and user-friendly graphics by streamlining data manipulation and data analysis methods.
• Solid knowledge and experience in R Shiny framework development to build web-based applications for clinical trial data such as creating action filters, parameters, and calculations.
• Participate in building R server infrastructure and hardware configuration and publish R Shiny interactive dashboards on R server.
• Participate in creating packages in R that involve applied clinical trial data mining for analytics of data solutions.
• Responsible for the validation of R Shiny framework deliverables derived both from internal development and from vendors.
• Communicate and interpret the applications of data visualization dashboards to end users.
• In alliance with statistical programmers and statisticians to ensure data deliverables and data sources are accurate and efficient. Be able to recognize inconsistencies and to initiate resolution of data problems.
• Synergize with statistical programmers and statisticians to test, clean, and standardize data to meet business requirements.
• Maintain the complete and auditable documentation of all R programming activities.
• Provide input and evaluate machine learning tools in R Shiny framework development.

Qualifications:

• High degree of technical competence and communication ability, both oral and written.
• Competent in SAS programming and Macro 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.
• Demonstrated excellent skills of oral communicating data-driven insights in a creative and effective manner and of describing and interpreting the abstract concepts to both technical and non-technical audience verbally and visually.
• Ability to understand application requirements and business requirements, search patterns and relationships between the mined clinical data, and convey them to the development teams and end users.
• Proven ability to participate in multiple and concurrent BI dashboard design and development projects.
• Prior R Shiny framework development is a plus.
• Knowledge in SAS language is a plus.
• Knowledge in clinical trial data is a plus.
• Knowledge in JavaScript is a plus.

Education and Experience:

• MS in Statistics, Computer Science or a related field with 0 - 3+ years of relevant experience; OR BS in Statistics, Computer Science or a related field with 5+ years of relevant experience.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled