*Title: Clinical SAS Developer* *Duration: 12 months*
*Job Description: _**REMOTE CLINICAL SAS DEVELOPER* SAS Clinical Programmer - Team Lead op 3-5 Skills: 1. SAS Programming 2. Good communication 3. Previous exp. working in pharm/biotech biometrics and stat programming environment 4. Ability to work independantly with limited supervision 5. BS or equivalent work experience Food and Drug Administration (FDA) Compliance-Experienced-2, Regulatory Policy and Controls Compliance-Experienced-2, Statistics: Knowledge-Expert-2 *Summary* The Advisor, Statistical Programming, Biometrics will typically support project teams in the development and validation of databases, tables, listings and figures utilized in Clinical Study Reports, Integrated Summaries and other analyses as contracted. The Advisor, Statistical Programming, Biometrics may also focus on the development of CDISC data conversion projects consisiting of database specifications, metadata management, and electronic deliverables. The Advisor, Statistical Programming, Biometrics will also be required to support project teams in the development and validation of department tools and applications. The Advisor, Statistical Programming, Biometrics may be required to support the Biometrics Global Leader in the preparation of Proposals, Statements of Work and Change Order contracts and may act as a subject matter expert when the need arises. Client visits and some travel to CSC sites may be required. The Advisor, Statistical Programming is a mid level position requiring staff members to work independently with little support from project or department leadership. Advisor level programmers are expected to be assigned the most challenging elements of a clinical programming project. *Description*: Provides clinical programming technical leadership and expertise to client project teams. Reviews and implements project specifications to ensure meeting project deliverables and timelines. Reviews and implements project validation activities to ensure quality of final deliverables Supports development of study metadata utilized in submission of electronic data packages. Works directly with client staff on Biometrics and CDISC data conversion submissions projects. Designs, develops, evaluates and modifies SAS programs to analyze and evaluate clinical data (Statistical Programming Focus) Designs, develops and validates CDISC data conversion specifications, data definition files and annotated case report forms (CDISC Analyst Focus) Technically support the preparation of Biometrics deliverables including, but not limited to, submission CRT databases, tables, listings and graphs for clinical study reports, statistical data packages (Statistical Programming Focus) Ensures timely completion of regulatory submissions. Assists in the development and maintenance of departmental SOPs, policies, and work instructions. Compliance with all department metrics reporting and tracking systems Support, as needed, department management in the preparation of Proposals and Statements of Work contracts. Client site visits and travel to other CSC site may be required. *Qualifications* • Excellent written and oral communication skills (English). • Extensive SAS experience in a Clinical environment. Minimum 7 years. (Statistical Programming Focus) • Operational CDISC conversion experience. Minimum 5-7 years (CDISC Analyst Focus) • Expertise in CDISC data standards including the SDTM, ADaM and SEND models. (CDISC Analyst Focus) • Able to demonstrate a strong understanding of CDISC standards. (Both focuses) • Hands-on experience with SDTM programming within FDA submission. • Hands-on experience with ADaM programming within FDA submission. • Hands-on experience with reporting programming within FDA submission • Able to demonstrate excellent knowledge of particular SAS programming skills such as Macros SQL SAS Graph Proc Report SAS Stat • Strong working knowledge of electronic data submission requirements including data definition preparation and aCRF development. (Statistical Programming Focus) • Advanced working knowledge of electronic data submission requirements including data definition preparation and aCRF development. (CDISC Analyst Focus) • Experience in writing and adhering to SOPs. • Interview job applicants • Recommending candidates for hire • Counseling and coaching junior staff • Support the evaluation of work processes • Answering questions related to work methods • Work experience with a US company. • Educated in US. • SAS certification (Statistical Programming Focus) • CDISC training (CDISC Analyst Focus) -- Thanks, *Srinadh Reddy* *SILTEK CORPORATION* *people. technology. innovation* 300 Brickstone Square Suite 201 Andover, MA 01810 (978) 475-2500 Direct (978) 623-7201 Fax *[email protected] <[email protected]> *www.siltekcorp.com -- You received this message because you are subscribed to the Google Groups "Open Source Erp & Crm" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/open-source-erp-crm. For more options, visit https://groups.google.com/d/optout.
