What are the responsibilities and job description for the Director Biostatistics position at Connect Life Sciences?
As the Director Biostatistics, you will spearhead the statistical efforts of a clinical program, playing a key role in the clinical development plan, regulatory submissions, and overall data strategy. This role requires strategic involvement in program teams, authorship of statistical sections in study documents, and direct oversight of outsourced statistical functions.
- Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams. Make strategic contributions to the clinical development plan.
- Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards.
- Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy.
- Develop and review statistical analysis plans for individual studies and integrated summaries of safety / efficacy (ISS / ISE). Create and edit statistical outputs shells.
- Provide statistical input during CRF design to ensure alignment with study objectives and analyze requirements. Oversee and quality control results from statistical programmers or CROs.
- Contribute to clinical study reports by authoring statistical sections and interpreting study results. Support the preparation of scientific publications and presentations.
- Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.
- May manage direct reports, as needed, providing guidance and professional development.
Skills and experience you’ll bring :
