Hi ,
Greetings for the Day!!!!....
This is *David *from *Ramsoft Inc.* Hope you are doing well and appreciate
for your response. We have a very good openings for *CDI Metadata
Analyst (SAS Clinical Data Analyst)* Positions with our *Direct Client.*
Please go through that and revert me with your word formatted profile along
with below mentioned details to *[email protected]
<[email protected]> / [email protected]
<[email protected]> :*
*Role: **CDI Metadata Analyst (SAS Clinical Data Analyst)*
*Location: Cambridge MA*
*Duration : 1 yr*
*JD:SDA (Statistical Data Analytics) Department CDI Metadata Analyst*
*Works with the CDI Lead to develop processes and technology for collecting
clinical trial metadata. Includes: *
* Develops a standardized process for use by programming operations to
create metadata during study conduct for prospective study activities.
* Develops associated tools (SAS macros) for metadata creation during study
conduct.
* Develops a standardized process for use in metadata curation for
retrospective (locked) studies.
* Develops associated tools, as necessary, for retrospective metadata
curation efforts.
* Facilitates creation of associated controlled documentation for process
and tool use.
Trains study program teams on the use of metadata curation processes and
technology to ensure curation of quality metadata.
Manages the metadata curation efforts, ensuring quality data. Includes:
* Assists the CDI Lead in the development of a long term plan for metadata
curation.
* Develops quality control measures.
* Partners with other departments in BIIB for the publication and
maintenance of the curated metadata.
Participates in Development activities, including programming, for the
re-use of clinical trial data in support of secondary analyses.
*3. Unique Knowledge & Skills *
*Technical Skills *
* (Must Have) Minimum of 5 years of clinical data programming and/ or data
management, including SAS programming, experience working in the
biotechnology or pharmaceutical industry.
* (MH) Education: BS/BA or equivalent in a discipline related to Clinical
Data, Technology, Computer Science.
* (MH) Demonstrated experience with CDISC SDTM standards, including Trial
Design, and experience manipulating data into standard format required.
* (MH) Demonstrated experience with interpreting clinical study protocols,
for purposes of study setup / metadata curation.
* (MH) Metadata Management, SQL, and SAS experience required, with
demonstrated programming language experience.
* (MH) General software skills: Outlook, MS Access, MS Word, MS Excel, MS
Project, Visio, Business Objects, SQL, SAS.
* (Nice To Have) Aware of current global regulatory guidelines relevant to
Statistical Programming and Standards, as well as related Pharma
Development SOPs, guidelines and Best Practices In-depth knowledge and
understanding of the drug development process.
* (NTH) Exposure and awareness of emerging technologies, as they pertain to
metadata collection and management.
* (NTH) Knowledge of GCP and other regulations.
*Soft Skills *
* (MH) Excellent oral and written communication skills.
* (MH) Ability to manage multiple projects and processes simultaneously.
* (MH) The candidate should be detail oriented, identify issues and assist
in problem solving in a timely manner.
* (MH) Ability to handle multiple (changing) priorities under tight
timelines.
* (NTH) Proven ability to build relationships and manage expectations with
key data management service providers who represent single or multiple
functions.
* (NTH) Internal customer management, team effectiveness and enhancement,
timeline management, proactive problem solving ability.
* (NTH) Ability to work well in a fast-paced environment.
Thanks & Regards,
David
Email: [email protected] / [email protected]
Tel: 732-666-0014
Fax: (480) 393 4994
Web: www.ramsoftinc.com
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