AbbVie Manager, Statistical Programming in Sunnyvale, California
Manager, Statistical Programming
Location: Sunnyvale, CA
# of Openings: 1
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 effciency, 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.
Train junior programmers, teach efficient programming techniques and guide the programmers in need of assistance.
Key Accountabilities/Core Job Responsibilities:
Independently translate and implement algorithms and protocols in a high performance computing environment and prepare reports of results in a reproducible manner.
Provide statistical programming support for multiple clinical projects or therapeutic areas & performance management for statistical programmers.
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.
Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards; the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities
Responsible for determining the scope of the peer review and for ensuring peer review has been completed for all activities for the assigned projects
Responsible for developing and maintaining good client relationships.
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 activity.
Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies.
Effectively mentor statistical programming and non-statistical programming peers with regard to functional operations.
Develop database checks for routine and non-routine situations.
Design and develop various software and systems to effectively generalize programming effort across projects.
Responsible for formulating proposals for new utilities as well as presenting information on existing utilities and identifying opportunities for productivity improvements and formulating implementation plans.
Participate in the development of standard data quality assurance tools.
Responsible for the creation and accuracy of derivation programs for routine and non-routine situations.
Responsible for the creation and accuracy of submission data sets and analysis programs for routine and non-routine situations.
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.
Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards for submission data sets & programs.
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 requests.
Ensure internal consistency of output and assess consistency with other activities for the project, as applicable.
High degree of technical competence and strong communication ability, both oral and written.
Fluency in 2 or more relevant programming languages, such as R, Python, Perl, Ruby, Java, or C++ preferred.
Competent in SAS programming and Macro development.
Demonstrated proficiency in a Linux environment and high performance distributed computing with system administration experience desired.
Experience handling and managing data/software associated with high-throughput instruments for genetics and/or genomics.
Experience with cloud computing, version control, and GPU programming skills
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.
Project lead experience required.
Management experience not required.
Strong communication skills in a collaborative environment.
Expertise in the use of SAS Macros.
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 8+ years of relevant experience; OR BS with 10+ years of relevant experience.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled