Associate Director, Statistical Programming - San Francisco, CA
Our client in San Francisco, CA is seeking an Associate Director Statistical
Programming.
Description
Reporting to the Director of Biometrics, the Associate Director of
Statistical Programming will be an integral part of the Biometrics group,
and will work closely with the Director of Biometrics to provide statistical
programming support to data management, regulatory affairs,
pharmacovigilance, and all clinical development projects as well as to
define and maintain various internal programming standards.
Responsibilities: • Group Head of Statistical Programming. • Responsible for
all statistical programming activities, indication or publication
activities, and data base structure. • Provide statistical programming
support to generate derived analysis data sets, tables, listings, and
figures for individual studies and ISS/ISE; • Participate in the review of
statistical analysis plans, draft table specifications, design analysis data
sets, and provide mapping files for analysis data sets. • Review, and
comment on CRFs, annotated CRFs, and edit checks documents. • Participate in
operations meetings and address issues that may influence statistical
programming. • Support and participate in the preparation of study reports,
regulatory submissions, and annual IND safety update reports. • Perform
additional analysis and data validation. • Cooperate with CRO statistical
programmers and validate their work. • Develop and contribute to Biometrics
SOPs and working documents related to EDC studies, FDA requests, independent
validation, and general statistical programming processes.
Requirements
• Masters degree in a statistics, • At least 10 years of biopharmaceutical
experience as a Statistical Programmer, • Five years of supervisory
experience, • Extensive experience in organizing regulatory submissions, •
Extensive experience in BLA, NDA/s NDA submissions. • Strong leadership
skills and team work spirit.
Apply:
Please forward your Word formatted resume, cover note and salary requirement
to resumes At workwondersstaffing.net.
