Dear Allstat, 

Please find the details of our latest permanent Senior SAS Programming
Opportunity.

If this role is of interest to you please send an updated CV to
[log in to unmask] or alternatively for a private consultation you
can reach me on +44 (0)207 922 7126.

JOB DESCRIPTION

The purpose of this position is to provide program-level statistical
programming expertise by:
• Designing and executing analysis deliverables to meet the requirements of
clinical studies. 
• Managing and enforcing standards for derived datasets and analysis outputs
to maximize global data integratability. 
• Directing the work of external vendors providing statistical programming
services to achieve quality and timely, cost-effective study deliverables.

FUNCTIONS

• Represent the statistical programming function in support of assigned
clinical studies and programs lead from the US or EU.
• Define and manage derived data set and reporting standards using
respective Global standards.
• Independently develop, execute, and maintain SAS computer programs,
including macro programs, according to Statistical Analysis Plans (SAPs),
cross-study analysis and data specifications, or analysis requests to:

-Produce statistical analysis output (tables, listings and graphs) to
support generation of critical (flash) clinical study results, cross-study
results for investigator brochures, regulatory submissions, or ad-hoc and
exploratory analyses involving descriptive and simple inferential
statistics.

- Perform data manipulations, including creation of derived data sets,
related to the production of the statistical output.

- Verify (QC) study and cross-study analysis results or derived data sets
produced by another statistical programmer, statistician, or an external
vendor.

• Identify vendor requirements and participate in the evaluation/selection
of BDM vendors. Provide technical oversight of statistical programming
activities of external vendors to assure timeliness and quality of analysis
data and statistical outputs. Review and approve key statistical programming
vendor deliverables.
• Define and manage transfers of all externally produced analysis data and
outputs.
• Archive statistical outputs and related documentation according to
standards.
• Anticipate and communicate resource and quality issues that may impact
deliverables or timelines.  Propose and implement solutions. Escalate issues
to management as appropriate.
• Contribute to increasing efficiency of the Statistical Programming
function through development of programming utilities, data and output
standards, and improvements to the statistical computing environment.
Support implementation of such utilities, standards and process
improvements.
• Comply with all applicable regulatory requirements, standards and
procedures.
• Perform other duties as assigned.

REQUIREMENTS

• BSc in Statistics, Computer Science, or other related field ; or MS in
Computer Science, Statistics, or other related field with SAS programming
experience in the pharmaceutical/CRO industry.
•Advanced knowledge of SAS programming language and Base SAS, SAS/GRAPH
parts of SAS software, good knowledge of common procedures in SAS/STAT. 
•Good knowledge of general programming and computing principles, experience
with Windows NT and UNIX operating systems, and common software products and
technologies used in conjunction with SAS, expertise in office software
(Microsoft Office).
• Good understanding of clinical study documents (protocol, CRF, SAP,
Clinical Study Report).
• Working knowledge of clinical study designs, common analysis methods,
descriptive and simple inferential statistics, and data presentation
practices.
• Good knowledge of data management processes, including EDC processes,
documents and data flow in clinical trials.
• Basic knowledge of drug development process.
• Good knowledge of FDA and ICH regulations and industry standards
applicable to clinical study data and reporting on clinical trials,
including data standards for electronic submissions.
• General project management skills.
• Good oral and written communications skills. 



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