Improving quality-of-life through innovations in urology.
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule β3-adrenergic agonist being evaluated for overactive bladder (OAB). In addition to OAB, vibegron is being evaluated for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Principal Biostatistician will serve as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
The position is based at Urovant’s site in Durham, NC and reports to the Senior Director, Biostatistics, Programming & Data Management.
- Serve as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies.
- Oversee design and execution of statistical methods, statistical analyses, and results, which includes reviews of statistical analyses of other statisticians and interpretation of results from simple to complex clinical studies and oversight review of TFLs and derived datasets.
- Oversee statistical deliverables to ensure compliance, in timing and quality, with ICH guidelines, as applicable to statistics.
- Prepare and review statistical methods and results sections for the clinical study report (CSR).
- Develop statistical analysis plans and reporting specifications from simple to complex clinical studies.
- Provide input into the development and review of case report forms (CRFs), edit specifications.
- Contribute to clinical study protocols and clinical study reports.
- Review simple to complex randomization specifications and dummy randomization schemes for data sets containing mock treatment codes.
Education and Experience
- PhD in Statistics with a minimum of 4 years of experience or Master’s in Statistics or related field with 6+ years of pharmaceutical experience preferred.
- Strong statistical technical expertise, with significant knowledge of clinical study designs and statistical analysis methods.
- Knowledge and experience in computing tools such as SAS (Statistical Analysis System).
- Extensive knowledge of drug development process and FDA and ICH guidelines.
Essential Skills and Abilities
- Strong analytical and problem solving skills.
- Self-starter, work independently, prioritize tasks and has initiative to take on unfamiliar tasks.
- Strong communication skills, (both written and oral).
- Demonstrated leadership capabilities for cross functional teams.
- Able to work in a fast-changing environment.