New Perm position in NYC for SAS Programmer!!

New Perm position in New York City, NY (relocation can be provided!)

Send resumes to sruesch@csg-inc.com

TITLE: Statistical Database Manager, Reproductive Health Program

JOB DESCRIPTION
The statistical database manager will play a key senior role with the data management and statistical group and will be responsible for performing specific data management, programming, and statistical analysis functions that will ensure timely progression of activities associated with Reproductive Health program (RH) clinical trial data. This individual will contribute to the organization of data for a new drug application (NDA) for submission to the US Food and Drug Administration and other regulatory bodies.

RESPONSIBILITIES
Individually and in collaboration with the data management and statistical teams, perform relevant aspects of data management for selected RH clinical protocols within the Center for Biomedical Research (CBR).
Provide overall support to data management personnel for selected studies, including building SAS-based edit checks and SAS-based data cleaning programs.
In collaboration with senior statistical scientist, assume responsibility for outlining and developing required statistical analysis (including specifications) and/or statistical analysis plans (SAPs) for Phase 2 and 3 studies or other statistical analysis requirements (e.g., analyses needed for internal/external meetings and publications).
Contribute to the development of tables and reports/presentations/publications (e.g., annual study reports to regulatory bodies).
Collaborate with statistical and data management groups to define statistical/analytic table shells in SAS programming language as required for completing study reports (includes writing SAS programs to produce defined statistical/analytic tables).
Be responsible for coordination with senior scientist, data manager, medical writer, and director of clinical development to meet timelines and deadlines for various clinical trial reports, including timelines for data cleaning and data lock for recently completed Phase 3 clinical trial.
Be responsible for data archiving in accordance with regulatory requirements.
Contribute to the development of instruments needed for clinical trials, including case report forms (CRFs), questionnaires/diaries involving clinical trial participants, various tables and reports/presentations as needed (e.g., annual study reports to regulatory bodies).
Develop and maintain internal operation manual to ensure the quality and efficiency of the data management activities, including departmental standard operating procedures (SOPs) as needed.

QUALIFICATIONS
Master's degree/Ph.D. in computer science and/or statistics with a minimum of five years' clinical data management and statistical analysis experience.
Data management and statistical analysis experience with investigational pharmaceutical products (experience with women's health products preferred).
Experience and expertise with data management software (knowledge of DataFax is a plus).
Demonstrated ability to develop and write data management and statistical analysis plans.
Experience in preparing data for publications and writing for publications.
Experience with regulatory requirements, including FDA, regarding validity of data and data presentations required for submission of NDAs and annual reports.
Experience with tasks of clinical trial statistician, including ability to apply/critique appropriate statistical analysis programs for contraceptive trials.
Detail-oriented with good analytical skills and in-depth knowledge of and experience with SAS.
Experience with data archiving.
Demonstrated negotiation and interpersonal skills in order to interact with individuals across all levels of the Council's global organization; effective oral and written communication skills are essential.
Knowledge of and experience with MedDRA and/or WHOART coding is highly desirable.
Strong sense of professional responsibility and work ethic.