Manager, Clinical Programming

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:

Lead the Clinical Programming function with minimal supervision. Responsible for highest standard of data quality and drive programming 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 and collaborate with clinical data managers, statistical programmers, clinical operations, and biostatisticians. Train new programmers, teach efficient programming techniques and guide the programmers in need of assistance. Manage clinical programmers.

People Manager Responsibilities:

• Provide training and performance management for staff.
• Demonstrate leadership competencies, builds relationships, and promotes teamwork within the statisticsl programming organization and across functions.
• Responsible for making recommendations and decisions related to processes, standards and resource management.
• Responsible for management and development of staff.
• Manage statistical programming staff by appropriate assignment of responsibilities, defining scope, monitor and quantify, and reviewing activities/progress ensuring effciency, accuracy, and timliness so that projects are delivered on time with suitable quality.
• Establish high expectations and goals to ensure organizational success and lead staff to meet or exceed those goals.
• Create an organization that executes efficiently and is committed to meeting goals.
• Encourage a culture of open, honest communication where all are encouraged to express their views.
• Actively manages resources and staffing by clear assignment of responsibilities and scope with correct balance of expertise of programmers to ensure a nimble and motivated team.
• Provide appropriate background and motivation to staff.
• Ensure that self and staff are compliant with training requirements.
• Arrange appropriate training opportunities for staff to facilitate their timely career development.
• Recruit, train, and orient all new hires; accountable for development (technical and interpersonal skills ) of individuals within the group.
• Review project timelines and plans; provide headcount forecast for projects.
• Mentor statistical programming staff with regard to functional operations.
• Train junior programmers, teach efficient programming techniques and guide the programmers in need of assistance.

Key Accountabilities/Core Job Responsibilities:

• Responsible for coordinating, facilitating and participating in all CPG activities from CRF design to database lock with minimal oversight.
• Monitor progress and conduct of their respective projects, including all data conversion, coding, cleaning and QC activities to ensure all remain on target to project timelines
• Contribute towards process improvement, data standards and efficiency gaining initiatives within clinical programming role while working with data management and biostat leadership as needed
• Accountable for review and quality of all programmed results.
• Monitor and quantify, efficiency, accuracy, and timeliness of Clinical Programming group.
• Recruit, train, and orient all new hires; accountable for development (technical and interpersonal skills of individuals within the group.
• Review project time lines and plans; provide headcount forecast for projects.
• Ensure technology updates occur as needed.
• Establish process, methods and tools for giving guidance to programmers when they need assistance in programming, training staff within clinical business areas.
• Work with Director of Statistical Computing to establish and ensure adherence with programming and output standards and utilization of systems and processes to maximize efficiency of the statistical programming function.
• Lead the development of new processes and provide accurate and timely responses to complex requests from clients and guide clients on possible options for deliverables for non-routine requests.
• Lead Clinical Programming activities for multiple clinical projects across therapeutic areas.

Qualifications:

• Excellent programming skills especially in SAS.
• Demonstrated ability to debug SAS programs and assist programmers.
• Excellent problem solving, leadership, communication and interpersonal skills.
• Working knowledge of current regulatory requirements and guidance.
• 10+ years of supervisory experience preferred.
• Understand CDISC standards and applicability to clinical database design/capture and reporting.

Education and Experience:

• MS in Statistics, Bioniformatics, 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