Sr. Manager Statistical Programming

Location
01752, Marlborough
Posted
Mar 28, 2018
Discipline
Clinical, Clinical Data
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Provide statistical programming support to clinical trial analysis work and integrated analyses for regulatory submissions and various publications, posters etc. Support the Biostatistics function in statistical analysis including generating analysis data sets, patient listings, tables and figures for clinical trials. Develop and maintain the infrastructure for project files of SAS datasets and SAS code.

1. Provide statistical programming support to clinical trials for regulatory submissions and
publications, and ad hoc or post hoc analyses. Generate analysis data sets, patient listings, tables
and figures for clinical studies. 30%

2. Function as lead programmer on single or multi-protocol projects, and participate in project team
meetings. Assume protocol level responsibilities in statistical programming. Review protocol and
SAP, write/review analysis data specifications, etc. Interact with Statisticians, Clinical Data Programmers, Data Managers, Clinical Operations personnel and project manager to ensure the timeline and quality of analysis data and reporting. 30%

3. Independently validate SAS data sets and outputs from CROs or other programmers. Prepare
validation documentation. 20%

4. Develop and maintain SAS programming infrastructure, macros and standards. Adhere to the
company's and departmental SOPs, Working Instructions and Standards. Participate in the company's development and implementation of global analysis data standards, output formats, standard SAS programs, etc. 20%