Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.
Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.
Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
Perform 3rd level QC review on programming deliverables before their release to the clients.
Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
May lead programming efforts for drug development programs or for assigned client clusters.
Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.
May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.
Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.
Participate in statistical programming project bidding or bid defense meetings.
Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors.
M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
10 (M.Sc., M.A.)/9 (Ph.D.) years' related experience.
An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.
Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations.
Must have sound technical judgment and experience in process design and implementation in relevant areas.
Strong leadership and drive to achieve goals will be required.
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