Senior Manager, Statistical Programming
Company: Pharmacyclics, LLC
Posted on: May 20, 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 to produce analysis, reports and graphs on all PCYC drugs.
Review program codes and suggest alternative solutions that may be
efficient. Interact with GRAs, medical writers, clinicians,
statisticians, data management and medical affairs personnel, and
other members of PCYC R&D. People Manager 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 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
- Train junior programmers, teach efficient programming
techniques and guide the programmers in need of assistance. Key
Accountabilities/Core Job Responsibilities:
- Ensure technology updates occur as needed.
- Provide programming support to analyze clinical data and
generate reports and graphs on all PCYC drugs in the clinical
- Hire consultant programmers to meet short-term needs of
additional programming resources.
- 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.
- Accountable for review and validation of all programmed
- 7 years of experience in the pharmaceutical industry generating
analysis, reports and graphs for individual studies and ISS, ISE,
NDA submissions to FDA.
- Minimum of 2 years of management experience.
- Excellent programming skills especially in SAS.
- High degree of technical competency and strong communication
ability, both oral and written.
- Fluency in 2 or more or relevant programming languages, such as
R, Python, Perl, Ruby, Java, or C++ required.
- Competent in SAS programming and Macro development.
- Excellent problem solving, leadership, communication and
- Working knowledge of current regulatory requirements and
- Demonstrated ability to debug SAS programs and assist
- 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 9+ years of relevant experience; OR BS with 11+
years of relevant experience.
- B.S., M.S. or Ph.D. in statistics, computer science,
mathematics or a related field, required. #LI-SH19 Equal
Opportunity Employer Minorities/Women/Veterans/Disabled
Keywords: Pharmacyclics, LLC, Sunnyvale , Senior Manager, Statistical Programming, Executive , Sunnyvale, California
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