ClinChoice

Provide oversight development of datasets ,Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines. Accountable for oversight of statistical programming deliverables for inhouse and outsourced projects.

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Responsible for assuring that data for statistical analyses are complete, accurate and consistent.

As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects, drive strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies, and ensure compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.

Lead and oversee complex statistical analyses, provide high-level strategic recommendations, and guide junior analysts in the execution of observational research. This leadership position combines technical expertise with client-facing responsibilities, allowing the successful candidate to influence key decisions within our client’s RWE and cross-functional teams.