Principal Biostatistician

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, is a β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.  In addition to OAB, Vibegron is being developed for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of 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.

Responsibilities include:

  • 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.

Associate Director Process Chemistry

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.

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, is a β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

Urovant’s second investigational product candidate, hMaxi-K, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

The Associate Director Process Chemistry will lead development of small molecule active pharmaceutical ingredients (API) from a development stage to commercialization and support all aspects of supply chain requirements for API.

The position could be based at Urovant’s site in Durham, NC or Irvine, CA and reports to the Vice President, CMC.

Responsible for directing and overseeing all aspects of the manufacture of small molecules API’s at Urovant’s contract manufacturers organizations (CMOs) including small molecule process development, scale-up, technology transfer, validation, launch, and on-going manufacturing support and process improvements. Responsible for API supply chain development and coordinating manufacturing to ensure adequate supplies to support clinical and/or commercial demand.

Support the CMC team in writing IND and NDA’s drug substance Quality sections, and also provide support of business development activities and due diligences.

  • The employee must conduct their work activities in compliance with all Urovant Sciences, Inc. internal requirements, per ICH GMP/ Good manufacturing and ISO requirements and with all applicable regulatory requirements. Urovant Sciences, Inc. internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
  • Responsible for establishing and/or managing supply chain for drug substance and leading and overseeing all aspects of process development and manufacture of Urovant’s API’s at CMOs around the world and ensures adherence to project timelines to support clinical and/or commercial supply in line with business objectives.
  • Reviews and provides oversight of all documentation related to the production of the API including but not limited to: development, scale-up, technology transfer and validation protocols/reports batch records, deviations, process excursions, protocols and reports. Contributes in setting up specifications for starting materials, intermediates and drug substance. In conjunction with the CMO and other groups adjudicates deviations and leads or conducts a root cause analysis and implement proposed corrective actions at CMOs.
  • Collaborates closely with Regulatory Affairs to support CMC activities including writing, reviewing and managing all drug substance sections for any regulatory submission, and ensuring that documents are prepared in accordance with regulatory guidelines, internal standards and SOPs.

Education and Experience

  • Master’s or PhD degree in organic or process chemistry, chemical engineering or related field.
  • 5 to 10 years experience in the pharmaceutical industry working in development/pilot plant/commercial manufacturing operations for pharmaceutical APIs (drug substances).
  • Demonstrated scientific knowledge relevant to development and manufacture of drug substance.
  • Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations.
  • Strong project management experience with cross-functional team leadership and participation skills.
  • Requires strong understanding of technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.


Essential Skills and Abilities

  • Self-starter who can work independently and can prioritize tasks.
  • Strong communication skills, (both written and oral) including presentations to senior management and external audiences and experts.
  • Strong understanding and working knowledge of cGMPs for biologics pharmaceutical development and commercial operations.
  • Leadership capabilities for cross functional teams.
  • Ability to work across locations and time zones; must be able to travel.