Associate Director, Statistical Programming

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POST DATE 8/16/2016
END DATE 12/19/2016

A New Beginning - Genesis 2 Bridgewater, NJ

Bridgewater, NJ
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Full Time
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* Lead global data standardization activities in the Biostatistics and Programming (B&P) organization.
* Collaborate across the CSO (Clinical Sciences & Operations) platform to support the development, maintenance and governance of clinical data standards and tools in B strong interpersonal skills that demonstrate initiative and motivation; proven ability to solve problems; excellent verbal and written communication skills in a global environment.
* Strong skills in project management and team leadership. Ability to effectively organize and manage multiple assignments, from project start-up through finalization.
* Demonstrated experience in the development and implementation of standardization methodology within at least one therapeutic area in pharmaceutical clinical development.
* Experience (direct or advisory) with the preparation of the full package (SDTM and ADaM) eSub deliverables (e.g., tabulation and analysis datasets, define.xml, annotated CRF, SDRG, ADRG, etc.) in compliance with current regulatory standards guidance and involvement in submission planning.
* Experience in participating in end-to-end global standardization initiatives.
* Experience in participating in industry-wide clinical data standards activities.
* SAS programming experience with focus on programming process optimization.
* Experience with a metadata repository tool a plus.


* Lead activities to define and/or improve strategies for the implementation of the global data standards in Biostatistics and Programming based on industry standards and regulatory requirements.
* Lead activities to support study level SDTM mapping as well as associated submission deliverables, including planning and tracking project activities, resource use and timeline.
* Lead support on data and submission standards to project teams to ensure high quality and timely eSub deliverables that meet industry standards and regulatory requirements; particularly with regard to SDTMIG assumptions and mapping strategies, statistical programming conventions, and CTD-CRT preparation (Define.xml development, CRF annotation, FDA submission expectations, use of Pinnacle 21, and SDTM compliance rule violation resolution).
* Reinforce the implementation of data standards within B&P through conducting trainings and workshops, and providing Q support the project teams, including their work with external partners and/or venders, to ensure submission readiness.
* Identify, author and review submission data standards related Guidelines and Work Instructions.
* Lead activities to develop, evaluate, and validate SAS macros and template programs related to the creation and validation of standard submission datasets.
* Support the identification, review, evaluation and implementation of new technologies related to clinical data standards.
* Lead or participate in data standards process improvement working groups.
* Participate in cross-entity end-to-end standards governance activities.


* A candidate with a BACHELOR OF SCIENCE degree or equivalent in a relevant scientific discipline and 12+ YEARS OF EXPERIENCEpreferably in statistical programming in the pharmaceutical industry.
* A candidate with a MASTER OF SCIENCE degree or equivalent in a relevant scientific discipline and 10+ YEARS OF EXPERIENCEpreferably in statistical programming in the pharmaceutical industry.

Base Salary - $110,000 to $155,000
Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Interview Travel Reimbursed - Yes

10+ to 15 years experience
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally

Also, please understand this may take time for both of us working together to help advance your career. I will do my best for you and never charge you anything for our time and efforts.

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