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 for multiple clinical projects across multiple therapeutic areas through own effort and those of their staff. Accountable for providing Statistical Programming support for multiple therapeutic areas.
Key Accountabilities/Core Job Responsibilities:
- Provide training and performance management for staff.
- Demonstrate leadership competencies, builds relationships, and promotes teamwork within the statistical programming organization and across functions.
- Responsible for making key 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 efficiency, accuracy, and timeliness 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.
- Demonstrate extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations.
- Oversee effort to determine and implement global company standards related to output design and programming conventions.
- Provide strategic guidance on the development of CRFs and database designs.
- Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications.
- Work collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas.
- Demonstrate an understanding of drug development principles.
- Anticipate potential problems within and across projects and develops appropriate contingency plans.
- Create escalation plans to ensure resolution of all issues at the therapeutic and project levels.
- Participates in and is viewed as a key contributor to cross functional initiatives.
- Effectively present information through planning and execution of meetings and presentations.
- Allocate resources to projects such that the correct balance of expertise and experience is maintained for all projects.
- Work collaboratively with the statistical programming management team to assess project resource requirements versus current staff.
- Ensure expenses for consultant programmers do not exceed the budget limitations.
- Accountable for identifying safety functional process needs, driving standardization, defining and implementing best practices for statistical programming solutions. Acquire necessary tools to improve programming efficiency and facilitate statistical interactive analysis for drug safety business function.
- Experience in managing safety team supported include AE management, signal detection and additional sub-components associated with the drug safety business function are highly desired
- Daily demonstrates a positive, ‘can do’ and service oriented attitude; detail-oriented with a commitment to accuracy. Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction, to accept responsibility for individual and team performance (accountability & ownership) and to evaluate business impact of decisions, follow through on agreed upon decisions, and remain flexible when needed
- High degree of technical competence and strong communication ability, both oral and written.
- Highly 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.
- Thorough understanding of ICH Guidelines and relevant regulatory requirements.
- Understand CDISC standards and applicability to clinical database design/capture and reporting.
- Knowledge in integrating SAS with other leading technologies such as Extensible Markup Language (XML), Microsoft Office, etc. to support electronic submissions.
- Knowledge of Pinnacle 21.
- Understand about reviewer’s guides and Define.xml.
Education and Experience:
- MS in Computer Science, Bioinformatics, Biostatistics, or related field with 10+ years of relevant experience; OR BS with 12+ years of relevant experience.
- Minimum of 4 years of management experience.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled