Senior Manager, Statistical Programming
Posted on: November 17, 2019
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 a clear assignment
of responsibilities and scope with the 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.
Keywords: AbbVie, San Jose , Senior Manager, Statistical Programming, Executive , Sunnyvale, California
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