Grand Rapids, Michigan
JOB DESCRIPTION SUMMARY
The Project Statistician is responsible for providing statistical expertise and data services project management (Data Management, Statistical Services and Medical Writing) for the company.
This includes clinical trial design, sample size, statistical methods, analysis population determination, and interpretation of statistical results, simulation work, and strategic and regulatory consultation. The Project Statistician is also responsible for managing data service from beginning to end, including effectively communicating project expectations to team members in a timely and clear fashion and working with management to estimate the resources needed to achieve project goals.
- Doctoral degree (Ph.D.), preferably in Statistics, or equivalent (At least 6 years clinical trial experience)
- Master’s degree (M.S., M.A.), preferably in Statistics, or equivalent (At least 8 years clinical trial experience)
- Prior experience demonstrating strategic and statistical thinking, effective leadership, project management and team skills, organizational abilities, and knowledge of clinical research development and theory, regulatory requirements, and Good Clinical Practice (GCP).
- Proficient in SAS with broad-based knowledge of statistical procedures.
- Comprehensive understanding of applied statistics and statistical theory.
- Intermediate knowledge of Clinical Data Interchange Standards Consortium (CDISC) regulatory requirements/relevant guidance documents
- Oversee and manage projects from beginning to end across departments involved in data services (Data Management, Statistical Services and Medical Writing).
- Effective leadership in determining appropriate analysis methods for an array of therapeutic areas and indications, including adhering to relevant SOPs, complying with regulatory requirements, coordinating training, and confirming the quality of the deliverable product.
- Meet the data services, quality, and documentation requirements of the company as well as the company’s clients.
- Design and/or review statistical methodology for clinical trials, marketing analyses, and any other analyses that support client research (e.g., scale validation).
- Develop and review statistical analysis plans (SAPs) and mock shells based on study specific documents, study design objectives and sound statistical methodology.
- Lead or participate in employee training within the statistical services group.
- Produce/Quality Control (QC) mock/final randomization lists (implement randomization plan).
- Create/QC SAS datasets and associated documentation for internal use and for regulatory submission (e.g., CDISC Study Data Tabulation Model [SDTM] and Analysis Data Model [ADaM]).
- Annotate/QC annotation of case report forms (CRFs) for submission datasets and publishing of annotated CRFs.
- Create/QC define documentation (define.PDF, define.XML) for submission datasets and publish define documents (where applicable).
- Produce/QC tables, figures, listings from mock shells (e.g., in SAPs, programming notes).
- Design/review/QC EDC export specifications and data export downloads for compliance with export specifications.
- Perform EDC user acceptance testing (UAT).
- Review and provide feedback on data services deliverables as an external reviewer for data management and medical writing.