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:
- This role is located in Basel
- This role reports to the Head of Data Science
- Supervisory: Statisticians at all levels (internally & externally)
Major Accountabilities:
- Contributes strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed.
- Provides statistical consultations and strategic inputs in terms of drug development for company's senior management and other staff within the company.
- Provides statistical expertise in the development of study protocols, clinical study reports, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes.
- Reviews and approves primary and secondary manuscripts of clinical trial results.
- Develops statistical analysis plans for studies, performs complicated statistical analyses, and oversees the generation of tables, listings and figures for study reports and manuscripts.
- Reviews regulatory documents for accuracy and appropriateness of statistical interpretations. Act as statistical liaison to FDA/regulatory agencies.
- Demonstrates ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration.
- Communicates effectively with internal team members, senior management, external experts, and regulatory authorities.
- Demonstrates ability to provide coaching and feedback to foster professional development while also supporting business goals.
Profile (Skills, experiences and qualifications required for the job)
- A PhD in Biostatistics/Statistics or related disciplines with 10 years of pharmaceutical experience including direct supervisory and management experience.
- Strong knowledge of statistical methodology in design and analysis.
- Experience with adaptive designs, Bayesian methods, and advanced statistical modelling desirable.
- Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines
- Strong knowledge of major statistical software programs such as SAS and/or R.
- Excellent analytical, problem-solving and computer skills.
- Excellent verbal and written communication skills and excellent inter-personal skills.
- The qualified applicant must be flexible, well-organized, and have the ability to work well under pressure.
- Fluent in spoken and written English.
