Senior Sdtm Programmer (Remote)

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.

Responsibilities

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

Qualifications

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.

Qualifications And Experience

• 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.

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About Us

Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.