Statistical Programmer III
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 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
- Independently implement algorithms and protocols in a high
performance computing environment and prepare reports of results in
a reproducible manner.
- Provide statistical programming support for a clinical project
or therapeutic area.
- Contribute to optimize existing pipelines and workflows, as
well as help establish new pipelines and workflows; retrieve and
organize complex data types and structures as needed.
- Responsible for compliance with applicable Corporate and
Divisional Policies and procedures.
- Communicate an understanding of statistical programming
concepts, basic clinical principles and act in accordance with
- Effectively mentor non-statistical programming peers with
regard to statistical programming practices and mentor statistical
programming/non-statistical programming peers with regard to
- 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
- Ensure clarity, accuracy and consistency of case report forms
(CRFs), database definitions, and specifications for analysis data
sets for individual studies.
- Review for consistency across studies within a project;
contribute with developing project conventions and verifying that
conventions are followed.
- Contribute with developing project conventions and verifying
that conventions are followed.
- Provide accurate and timely responses to routine and
non-routine requests from clients.
- Develop database checks for routine situations and non-routine
- Ensure accuracy of database quality assurance checks and assess
data accuracy and consistency.
- Responsible for the creation and accuracy of derivation
programs for routine and non-routine situations, including peer
- 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 and non-routine
- 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.
- Contribute in the development of new SAS Macros; responsible
for formulating proposals for SAS Macros as well as presenting
information on existing Macros.
- Contribute 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
- Be compliant with training requirements; effectively mentor
statistical programming peers with regard to functional
- Coordinate the statistical programming activities for 0-4
clinical projects within the same therapeutic area.
- Oversee the work of 0-4 Statistical Programmers/Senior
Statistical Programmers or contractors.
- Ensure internal consistency of output and assess consistency
with other activities for the project, as applicable.
- 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
- 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
- Ability to appropriately delegate assignments and review
deliverables so that projects are delivered on time with suitable
- 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. Education and Experience:
- MS in Statistics, Computer Science or a related field with 5+
years of relevant experience; OR BS in Statistics, Computer Science
or a related field with 8+ years of relevant experience. #LI-SH20
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Keywords: Pharmacyclics, LLC, Sunnyvale , Statistical Programmer III, IT / Software / Systems , Sunnyvale, California
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