Lead projects with higher level of complexity/challenges/difficulties, and lead efforts to resolve complex statistical programming issues or problems.

Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality, as well as earn client’s trust and repeat business.

May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.

Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.

Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. Perform quality control (QC) review of these documents prepared by others.

Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.

Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) checklists.

Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.

Create SDTM and ADaM define.xml files, and table of contents. Perform QC review of these files prepared by others.

Participate and/or lead programming teams in support of product regulatory submission related activities.

Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.

Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities.

Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.

Complete job-required and project-specific training. Comply with applicable Company and trial Sponsor’s Policies, SOPs, and WIs.

Document data and programming information in accordance with corporate SOPs and guidelines.

Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.

May lead programming efforts for assigned client clusters when required.