Imagine your child scratching herself so unstoppably through the night that she wakes with blood-stained sheets. Nothing soothes her. You haven’t slept through the night in years. At school, unable to focus, she takes off her shoes and socks to scratch her feet on the carpet. The itch is inescapable. She has a life-threatening liver disease, and it’s getting worse.
Now imagine that you work for a company with a chance to help this child and her family.
This is Albireo. We are relentlessly focused on liver disease with the belief that bile acid modulation offers an innovative way to treat numerous rare and more common diseases affecting people worldwide. We are building a collaborative, committed, employee-friendly company, as we work to make this vision a reality.
Albireo is a public clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat rare childhood liver disease and other liver or gastrointestinal diseases and disorders. Albireo has deep expertise in bile acid biology and a clinical pipeline of three mid to late-stage product candidates designed to act locally to restore normal bile acid levels and treat diseases associated with irregularities in bile acid biology.
Albireo’s lead program is developing a therapy to treat patients with Progressive Familial Intrahepatic Cholestasis (PFIC). The Company initiated its global phase 3 study of A4250 in patients with PFIC in 2018 and expects topline results in mid-2020, with a projected potential first regulatory approval and launch in 2021.
Albireo was spun out from AstraZeneca in 2008 and is led by Ron Cooper, Albireo’s first President & CEO. Ron Cooper is a global P&L leader who joined Albireo after a distinguished career at Bristol Myers Squibb, including serving as BMS’s President of Europe, where he was responsible for 30 countries and sales exceeding $4.5B.
Albireo is located in Boston, Massachusetts (Financial District), and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden.
Job Title: Direcor, Biostatistics
Reports To: Sr. Direcor of Biostatistics and Programming, Biometrics Department
Location: Boston, MA
Reporting to Sr. Direcor of Biostatistics and Programming from the Biometrics Department, the Director of biostatistics within the Biometrics Department is expected to act independently as the statistics subject matter expert for all clinical development programs and studies, including oversight of data management and statistical programming activities, while ensuring adherence to all regulatory requirements. H/she is responsible for providing broad statistical support and contributing strategically to project decisions, with a focus on clinical planning, study design, protocol development, sample size / power calculations and simulations, statistical analysis methodology, statistical analysis plan preparation, blinded in-trial data quality review, pre-database lock data quality control, supporting development of table / listing / figure templates, programming and production, oversight of contract or CRO resources, as well as preparation, integration and documentation of clinical regulatory submission package, in accordance with CDISC standards.
The Lead Biostatistician is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data and multiplicity handling. She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, execution and evaluation of clinical trials. In addition, she/he will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics deparment and also with clinicians, clinical operations, medical writing, regulatory affairs, information technology and other colleagues, service/technology providers, as well as external drug development agencies or organizations. She/he will have a good understanding and the capacity to sustain the dialog in consultations or advisory board meetings with biostatistical, clinical and regulatory key opinion leaders about clinical study design, execution and evaluation from the statistical perspective.
Key Duties and Responsibilities:
Equal Opportunity Employer
All applicants should be legally entitled to work for any employer in the U.S.
Note to employment agencies: Please do not forward any agency resumes.