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发帖数: 102 | 1 Senior Statistical Programmer – Full Time (San Francisco or Greater Bay
Area)
DESCRIPTION:
Serves as a lead programmer for assigned clinical study projects and is held
accountable for all expected deliverables. Responsible for the development,
validation, execution, maintenance, documentation, and archival of analysis
datasets and programming code used in the analysis of clinical trial data
targeted for regulatory submission. All programming must be consistent with
good programming practice and compliant with regulatory requirements. Work
interactively with biostatistics, data management, clinical and regulatory
personnel and other departments as appropriate. Interact with outside groups
, e.g., Data Management CROs and EDC vendors.
Responsibilities:
Act as a lead programmer for assigned projects/studies Understand and be
accountable for project deliverables Attend project study team meetings
Review CRF, data management plan, statistical analysis plan, and other
documents as appropriate (e.g. data transfer specifications with vendors)
Review and provide feedback on data provided by vendors Develop analysis
file specification Assign tasks to other programmers Track programming
status, including verification status In accordance with departmental
objectives, use and share prior experiences in solving complex problems in
creative and effective ways.
Plan, design, develop, implement, validate, and maintain software for the
monitoring, reporting, and analysis of clinical trial data in accordance
with department SOPs.
Collaborate with statistician and assist in the development of the
statistical analysis plan (SAP).
Help develop and review case report forms and assist in the review of the
clinical trial database system, structure, and validation.
Develop project specific and departmental standardized programming tools and
routines for analysis.
Facilitate communication with and provide guidance to CROs/external vendors
(data management CROs) to achieve defined objectives.
EXPERIENCE AND QUALIFICATIONS:
Strong communication skills
Ability to articulately communicate complex information to others and to
comprehend complex analysis issues. Being visible and approachable.
Ability to communicate verbally and in writing in a clear and timely manner;
ability to listen to and understand the clinical study team and statistical
programming department are required.
Ability to effectively express concepts and points of view in individual and
informal group situations.
Ability to present ideas in an organized and concise manner.
Strong problem-solving skill including debugging code, looking up reference
materials and documentation, and contacting appropriate support. Must be
able to exercise sound judgment within departmental practices in selecting
methods and techniques to solve problems.
At least 7 years of experience in clinical application development (using
SAS) in the pharmaceutical/biotech industry.
Experience in the preparation and/or defense of regulatory submissions is
required.
Proficiency with SAS/BASE, SAS/STAT, SAS macros, SAS/GRAPH, PROC SQL, and
PROC REPORT.
Must be familiar with basic statistical concepts, such as: linear regression
analysis, analysis of variance, hypothesis testing, non-parametric analysis
, categorical data analysis, confidence intervals, p-values and capable of
implementing these ideas in clear, concise SAS code for the purposes of data
analysis and reporting.
An understanding of clinical trial principles and regulatory requirements,
including a basic knowledge of FDA/ICH guidelines and the software
development life cycle; experience dealing with FDA/regulatory requests.
Strong familiarity with CDISC data structure including SDTM and ADaM.
Must be flexible and able to work both independently and as part of a team
within a dynamic, interdisciplinary.
Ability to prioritize and handle multiple tasks simultaneously is a must.
Strong documentation skills.
Bachelor’s degree, preferably in statistics, math, computer science, or
similar discipline is required. A Masters degree in statistics is strongly
recommended. |
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