M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or related fields
In-depth knowledge of clinical trial data processing and regulatory requirements
Experience in SAS programming and statistical analysis for regulatory submissions
Expertise in data standardization and its implications for clinical operations
Strong project planning and control abilities
Proven leadership skills and goal-oriented mindset
Responsibilities
Develop and maintain clinical trial data standards to align with industry regulations
Perform hands-on statistical programming for various phases of clinical trials
Create and document SDTM mapping and ADaM data specifications
Conduct quality control of documents and programming deliverables
Generate SDTM and ADaM define.xml files and review them for accuracy
Lead programming initiatives for drug development or specific client clusters
Mentor less experienced team members and provide technical guidance
Benefits
Opportunity for professional development through training and mentorship
Involvement in diverse projects across multiple clinical trial phases
Collaborative work environment with access to industry standards and practices
Contribution to impactful public health outcomes through clinical trials
Participation in strategic project bidding and client interactions
Full Job Description
Responsibilities:
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.
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.
Requirements:
M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
n 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.
