TITLE:                     Sr. SDTM Programmer Analyst

LOCATION:             WOODCLIFF LAKE NJ 07677

DURATION:            12+ months with extension possible

JOB DESCRIPTION:                                                                                              

• SDTM Programmer Analyst Must have strong, current SDTM Study Data Tabulation Model (SDTM) development and programming skills.
• Overall Purpose of the Role/Responsible is for the development of SDTM, SDTM + datasets for clinical study data, but especially development of SDTM mapping specifications, QC of programmed SDTM datasets, and possible actual programming of SDTM datasets for various studies across all therapeutic areas for the client.
• Collaborate with client and Accenture programming team (offshore) to define timelines, identify and resolve issues. Responsibilities/Authorities Strictly adhere to Accenture Standards (and client’s, as applicable) including Standard Operating Procedures, Guidance Documents, and Policies; Operational and Service level agreements; Metrics and Quality Measures
• Accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costs and timelines for assigned project(s) Act as onsite presence at target account(s) to build and execute client relationships. Expect 80 – 100 % on site time at client site in Woodcliff Lake, NJ Accountable for development and maintenance of cross-functional / cross-department processes related to clinical trials, SDTM, SDTM+, which may include specifications, programming, QC, and deliverables of SDTM related data for analysis and submission.
• Accountable for execution of cross-functional / cross-department processes related to clinical trials SDTM, SDTM+ development, including specification, programming, QC, and deliverables of SDTM data for analysis and submission Engages appropriate stakeholders in communication to create SDTM standards and process for transition of clinical data to SDTM and SDTM+. Includes Data Transfer Spec review for external data. Involved in extensive clinical team contact (Statisticians, Statistical Programmers, Protocol Data Managers (PDMs), etc. to understand dataset requirements for SDTM, SDTM+ in production. Accountable for SDTM datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of SDTM datasets such as clinical teams, with high quality and on time deliverables.
• Provides SDTM data production technology consultation to client Clinical Data Operations team related to SDTM data delivery and manages the activities of a team with a common focus.

BASIC QUALIFICATIONS:

• Minimum 10 years of relevant programming and drug development experience in CRO, Pharmaceutical or Biotech organizations (preferably in Phase I-IV trials).
• Bachelor’s degree required.

PREFERRED SKILL REQUIREMENT:

• Master’s Degree in Computer Science, Mathematics or relevant field preferred Knowledge of Pinnacle 21 and Define.xml creation.
• Expert in CDISC standards and applicability to clinical database design / capture and reporting
• Excellent SAS programming skills, (at least 7 years SAS experience)
• Expert knowledge in clinical trials with 5+ years’ experience working in a clinical project team environment meeting deadlines with quality deliverables
• Expert in integrating SAS with other leading technologies such as XML, Microsoft Office, etc. to support electronic submissions
• Expert in addressing & resolving technical challenges that connect SAS, CDISC and XML. Manage risks and escalate appropriately

THANK YOU,

SHIBU SINGHA

MANAGER - SERVICE DELIVERY

AVACEND, INC.

3155 North Point Pkwy Bldg. G

Suite 130, Alpharetta GA 30005

PHONE: 770-702-0134

SHIBU.S@AVACEND.COM

Required Skills Required Experience