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RM - Clinical Data Designer (Sr. SDTM Programmer/Analyst)
Ref No.: 18-03970
Location: Woodcliff Lake, New Jersey
Start Date: 09/03/2018
Duration:0-12 month(s)

Description/Comment:OTHER
LEVEL 8
Update 8.24.18 -
Prefer US Citizen, willing to review Green Card holders. Make sure to interview/evaluate in person. Do not submit unless you have had direct contact with the candidate, this will assist with fake profiles.
Relocation at the candidates expense.
Subtiers allowed, only one level down

Relocation allowed at their own expense Subtier only one level down. US Citizen ONLY. No VISA or C2C. Sr. 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 Client programming team (offshore) to define timelines, identify and resolve issues.
Responsibilities/Authorities
Strictly adhere to Client 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

Additional Job Details:Proven experience in development and implementation of clinical standards in a global pharmaceutical environment. Experience in consulting projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle Professional skill requirements: Excellent written and verbal communication skills Ability to lead and manage functional teams to meet defined goals Experience in working in a global team setting. Ability to work well with team members in other countries (preferably India) Strong work ethic in performing daily activities Ability to constructively manage internal team and client relationships Good time management ability in performing role duties Good problem-solving skills and ability to reach mutually acceptable solutions Act as a team player in client and internal projects / initiatives