Lead SDTM SAS Programmer (Remote)

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Ihre Aufgaben

Working under the direction of the Technical Manager, Associate Director or Director, Statistical Programming, the Lead SDTM SAS programmer manages and leads programming activities for the creation and validation of SDTM domains implementing CDISC and client standards for the reporting of clinical study data.

SDTM Lead Roles and Responsibilities

• Initiate SDTM Kickoff meeting with study management team (SMT)

• Set up monthly "Data and SDTM review meetings" for which "Data and SDTM findings log" will be source. Lead will go over the Data issues and get any SDTM findings from SMT team.

• Annotate SDTM CRFs

• The Lead SDTM is responsible for writing dataset specification and programs on Key SDTM Domains

• Applies extensive domain and therapeutic knowledge in the programming of SDTM datasets to ensure quality and accuracy.

• The Lead SDTM may lead and also support multiple projects as an individual contributor

• Lead SDTM manages task assignments and makes sure that all the support programmers are utilized as needed across multiple studies without compromising quality and timelines of any deliverables

• Collaborate with key stakeholders to understand dataset requirements for SDTM production

• Lead SDTM may answer all questions from study team (Analysis, Biostatistician and programming) and set up any meetings as needed.

• Validate datasets using P21 and provide solutions to the issues and deliver high quality datasets.

• Generate & Validate SDTM Define.xml and provide justifications for any outstanding issues

• Key contributor to SDRG (Study Data Reviewer's Guide)

• Submit SDTM governance requests for review by Standards SMEs

• Communicates with key stakeholders to aid in further development of SDTM standards and process

  The Lead SDTM SAS Programmer works on the Client's systems and under the Client's SOPs/processes. The Lead SDTM SAS Programmer supports various projects across various portfolios (Therapeutic Area), by augmenting the Client's current staff.

Ihr Profil

• Minimum Education: BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 5 years of SAS programming experience with clinical trial data.

• Minimum Work Requirements: General knowledge of regulatory requirements and drug development process with a minimum of 5 years' experience with CDISC and SDTM compliance.

• Skills: Excellent organizational skills and good verbal and written communication skills. Ability to work independently is required.