Biostatistician/SAS Programmer/Clinical Data Management/Clinical Research Scientist

We are recruiting multiple clinical SAS programmers, bio-statisticians, Clinical Research

Scientist (CRA or CRS), Clinical Data Management programmers for clients in

Wilmington (DE), PA, NJ, Boston, MD and CA. Please send your resume to recruiting@techdataservice.com

Clinical SAS Programmers:



Develop, review, and/or perform validation of generic SAS macros;  Write clinical SAS programs/macros to support Regulatory Submissions (eNDAs); Use SAS/Base, Macro, Procedures, SQL, Graph, ODS to develop analysis datasets, generate listings, summaries, and figures; Familiar with the validation (QC) process, FDA update and ISS. Must have at least 3 years SAS programming experience in pharmaceutical, CRO or biotech companies.

 

Biostatisticians:

 Review or write protocol, write statistical analysis plans and design data presentations.  Must have MS or PhD in statistics and a minimum of 2 years experience in the pharmaceutical, CRO or biotech industry. Possess good working knowledge of SAS/Base, SAS/Macros, SAS Procedures and Report, SAS Graphics, SAS/Stat and SAS Version 8.2; Able to function in a team setting with good verbal and written skills. Experience with electronic FDA applications.

Clinical Data Management Programmer:

Have some SAS experience, prefer a few years experience in clintrial, oracle clinical, or INFORM in pharmaceutical industries.

CRA (Clinical Research Scientist):

Support clinical study start-up, design and execution and closeout activities.  Assist in preparation of sample Informed Consent Form, tracks investigator selection activities, assist in the preparation and distribution of study start up documents including investigator study file, enrollment logs, etc. Assist in the planning and preparation of Investigator Meetings. Contribute to collection of financial disclosure information.  Collect, review and track regulatory documents, conduct of site visits as appropriate, complete site correspondence and telephone logs as appropriate, maintenance and archival of study administrative files, management of clinical supplies and the preparation of study related presentation materials, SAE reporting and database reconciliation, tracking and reporting patient recruitment and retention enters and updates information into study delivery systems, proactively identifing study related issues.  Reconciliation of clinical drug supply, adverse events database and study file archive.  Assist in the preparation of clinical study reports and NDAs. Process and track CRFs for imaging and entry. Run validations and write queries according to data validation plan. 

Clinical Scientist:

3 years phase I study management experience necessary

University degree or equivalent experience

Good project management experience

Good ability to co-ordinate cross-functional teams

Excellent communication skills