Senior Statistical Programmer Analyst in Pasig City

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understa

Job Description: Help guide report strategy, help determine important safety concerns and review medical and medical safety content that will be included or discussed in the report, including but not limited to safety signals, health authority requests, safety-related literature, adverse event case reviews, benefit-risk assessments, and overall medical assessments and conclusions. Work in collaboration with contributing team members, particularly with the reports assigned to the Global Risk Assessment and Safety Physician. Review all stages of the report that are assigned during the report authoring process, record their recommended revisions, and indicate completion of their reviews in the corresponding systems. Key Responsibilities: Provide medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of Client products including, but not limited to, PBRER-PSURs and benefit-risk evaluations Review and contribute to strategy discussions, including determination of the important safety concerns and review of draft/final data, HA feedback topics, signals, and benefit-risk evaluation. Coordinate with Global Risk Assessment and Safety Physicians regarding PBRER steps and hand-offs and collaborate with other members of the report authoring team. Review the drafts and final reports as assigned and provide feedback, which may include pre-initial, drafts, drafts, final drafts, and final reports as assigned. Experience/Qualifications: Requirement: Medical Physician Technical Skills: the ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. Attention to detail: diligence in record-keeping and records organization, ability to manage high workload and critical issues, computer literate and proficiency in MS Office applications. Interpersonal skills: team player, displays initiative, strong communication, and presentation skills. I

JOB DESCRIPTION Responsibilities: Lead the Corporate System Project Specialist and responsible for the day-to-day operations of the ERP system. Collaborate closely with international cross-functional teams across multiple entities and system developers to identify improvement opportunities for the Microsoft Dynamics 365 ERP system and other company-wide applications. Analyze business requirements, develop functional specifications, prepare design documentation, and coordinate change requests, service requests, and budget alignment/approvals. Manage the full system project lifecycle, including project kickoff, planning, system issue tracking, timeline management, testing coordination, deployment, and implementation. Oversee testing activities and release schedules to ensure the successful delivery of system enhancements. Manage ERP timesheet operations and resource planning support. Monitor the company-wide timesheet and resource planning processes to ensure satisfactory completion and approval rates each month. Continuously evaluate and optimize timesheet management processes and training programs. Manage ERP user permissions and oversee the development, maintenance, and review of system-related standard operating procedures. Oversee issue tracking, resolution, and ongoing support for company-wide ERP system. Lead and facilitate ERP project meetings with stakeholders at all organizational levels. Design, develop, and deliver company-wide application training programs, including monthly ERP timesheet training for new hires, line managers, and project functional leads. Evaluate, initiate, and lead cross-functional standardization and automation initiatives that drive continuous business process improvement and operational efficiency. Skills and Qualifications: Bachelor’s degree or higher in computer science, science or a related field. Minimum of 5 years of relevant work experience. Strong written and verbal communication skills, with excellent analytical and problem-