Dear All Stat,
I am looking for statistical Programmer with either ADaM or SDTM expertise.
The position is primarily accountable for providing expertise, hands on
delivery and oversight of technical clinical data management activities
integrating Rave EDC, eSOURCE, third party data, mapping and transformation
of data to CDISCSDTM submission-ready tabulation packages as well as CRO
oversight for outsourced trials. This is a leadership position which will
also take on a Therapeutic Area Partner(TAP)role which provides end to end
operational leadership, strong analytical and problem-solving skills,
technical insight and expertise within a given TA/disease area. This
position may be responsible for the management and development of staff.
Also responsible for contributing to automation and innovation efforts.
Principle Responsibilities Include; Development of data transfer agreements
with ancillary data vendors ensuring use of standards, fit-for purpose data
models and transfer intervals. Create and review specifications for mapping
internal data review model for safety and quality review as well as
submission-ready CDISC SDTM. Ensure quality review of datasets (e.g.,
Pinnacle 21 compliance checking); ensure datasets are available for
stakeholder use (medical review, central monitoring ,adaptive decision
making, etc.) and compliant for database lock and submission-ready
tabulation packages. Therapeutic Area Partner (TAP) responsibilities
include; helping to drive operational excellence as a leader within the TA.
Understanding of portfolio demand and ensuring appropriate resources planned
and available to support demands. Helps build and strengthen partnerships,
community of practice as a leader within the therapeutic area of
responsibility. May provide supervisory support to staff, including
coaching, mentoring, training, career development, priority setting, etc.
If you are interested in the above, please get in touch.
Have a good weekend.
________________________________
Tom Oades
Biometrics Consultant
Tel: +44 (0) 2033255075
Mobile: +44 (0) 7944545303
Email and Skype: <mailto:[log in to unmask]> [log in to unmask]
LinkedIn: <https://www.linkedin.com/in/tom-oades-82a07a149/>
https://www.linkedin.com/in/tom-oades-82a07a149/
Website: <http://www.warmanobrien.com/> www.warmanobrien.com
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