VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.
Purpose of this role:
The Director, Biostatistics is responsible for ensuring statistical competencies are utilized in the best way to create value at Ironwood. The incumbent is actively involved in strategic, methodological, and operational clinical development activities in one or multiple therapeutic areas. The incumbent provides input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts and business development opportunities to ensure that statistical elements are in line with the overall product strategy. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training; leading in the development and adaptation of new statistical methodology in support of drug research and development; keeping current with regulatory guidance and requirements in the global environment; hiring, mentoring and managing employees to maintain a competent and qualified staff; selecting and hiring qualified and cost-effective CRO's to supplement internal resources; and monitoring the performance of CRO's to ensure high quality products and services.
Organizational Home:
Major Accountabilities:
Profile (Skills, experiences and qualifications required for the job)
•
Last updated on Apr 23, 2024
Boston, Massachusetts
·30+ days ago
Providence, Rhode Island
·30+ days ago
Boston, Massachusetts
·30+ days ago
Boston, Massachusetts
·30+ days ago
Boston, Massachusetts
·30+ days ago
Basel, Basel City
·26 days ago
Zürich, Zurich
·30+ days ago
Martigny, Valais
·30+ days ago
Zürich, Zurich
·30+ days ago
Zürich, Zurich
·30+ days ago
Zürich, Zurich
·30+ days ago