Associate Director, Statistical Programming
Company: Pharmacyclics, LLC
Posted on: May 21, 2019
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
- 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
- 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
- Mentor statistical programming staff with regard to functional
- 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
- Provide strategic guidance on the development of CRFs and
- 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
- 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
- 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
- Ensure expenses for consultant programmers do not exceed the
- 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
- 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
- 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
- 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
- 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. ---#LI-SH2 Equal
Opportunity Employer Minorities/Women/Veterans/Disabled
Keywords: Pharmacyclics, LLC, San Francisco , Associate Director, Statistical Programming, Executive , Sunnyvale, California
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