Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Candidate to provide statistical programming support and validation and help set specifications of analysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicable. Provide input into planning documents such as protocol, validation plan, and report analysis plan. Provide outputs for clinical study reports, integrated summaries and electronic submissions. Help respond to health authority inquiries for submitted dossiers. Establish and maintain sound working relationship and effective communications within biostatistics and statistical reporting and clinical research. Skills: Min 2-3 years of programming experience in HARP, the GSK programming environment is required. At least 8 years work experience in a Statistical (SAS) programming role preferably supporting clinical trials or in the pharmaceutical industry (5 years for Masters in Mathematics, Statistics/Computer Science or health science graduates). Advanced knowledge of / experience with SAS and other relevant programming software. Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills. Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent). Expertise in programming according to specifications of analysis datasets, pooled datasets, listings, tables and figures for clinical trials and submission activities. Working knowledge of database design/structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent). Good understanding of global clinical trial/project practices, procedures, methodologies. Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH). Oncology experience preferred Strong expertise in CDISC on the submission bucket including CRT programming will be a definite plus. Intermediate knowledge of office tools Fluent English (oral and written) Excellent in people interaction and be a collaborative team player.

Qualifications

Must have a BA/BS or equivalent experience in computer science, mathematics, statistics, life sciences, or related field(s). Additional Information Regards, Akriti Gupta Associate Recruiter(Scientific & Clinical Division) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3409 | Fax: 973.998.2599 Connect with us on - LinkedIn | Facebook | Twitter