[Employment] Associate Director, Statistical Programming - San Francisco, CA

[resumes At workwondersstaffing.net]

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.