Position: | Business Development Manager IVD | |
Location: | Virtual, | |
Field: | Life Sciences | |
Position Type: | Full Time |
Summary
This is a key BD role that will sell the entire client offerings with a concentration on building their Invitro Diagnostics Division. Can live anywhere in the country and willing to travel. Will need to have a background in the following areas. If you have what it takes then attach your resume for consideration and call Steve Soto, CPC at 203-558-1457.
- Preparation of statistical analysis plans (SAPs)
- Preparation of statistical analysis reports (SARs) for inclusion in regulatory submissions and assistance in preparing clinical study reports (CSRs)
- Assistance in preparing protocols and regulatory documents (IDE, 510(k), PMA)
- Tailored simulations for efficient clinical trial design, leveraging enrichment or stratification strategies
- Statistical support for analytical validation and clinical validation studies
- Designing and conducting regulated statistical analyses in SAS®/R
- Generation of submission-ready data sets, programs and outputs
- Analytical strategies for success in bridging studies
- Effective communication with key stakeholders or regulatory authorities