Current Openings

Responsibilities

Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell

Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages [Define.xml], and Reviewers guide [RGs] for all the deliverables Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells

Setup the folder structure for the assigned study as per the SOP

Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects

Provide the study status to the Project Manager/Client periodically

Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients

Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance

Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency

Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines

Provide guidance, mentoring, and training for junior team members as appropriate

Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis results

To ensure that the assigned team members are in compliance with SOPs and training requirements