Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.
Odevixibat is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes also referred to as the apical sodium dependent bile acid transporter (ASBT), that has minimal systemic exposure at therapeutic doses and acts locally in the gut.
Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC. The Company intends to complete regulatory filings in the EU and in the U.S. no later than early 2021, in anticipation of potential regulatory approval, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021, if approved. The Company also plans to initiate a pivotal Phase 3 trial of odevixibat in Alagille syndrome by the end of 2020, and to continue enrolling patients in the BOLD pivotal Phase 3 trial of odevixibat in biliary atresia. Albireo continues to progress its pipeline and expects to complete IND-enabling studies for a new preclinical candidate this year.
The U.S. Food and Drug Administration (FDA) has granted to the odevixibat PFIC program or elements of it fast track, rare paediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted odevixibat orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Its Paediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA also have granted orphan drug designation to odevixibat for the treatment of Alagille syndrome and primary biliary cholangitis. Albireo will commercialise Odevixibat in the US, Europe & Canada and will partner in remaining regions.
Job Title: Associate Director, Biostatistics
Reports To: VP of Biometrics , Biometrics Department
Location: Boston, MA
Reporting to VP of Biometrics , 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 department 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:
A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 10 years of relevant clinical biostatistics experience in pharma, biotech or medical device industry -OR- a Master's degree and a minimum of 12 years of relevant industry experience is required
Experience of rare disease clinical development and NDA is highly preferred; Comprehensive knowledge of statistical theory and methods
Demonstrated ability to apply statistical, programming, and data management knowledge to clinical studies and other supportive tasks
Expertise in SAS and R programming for data management, conversion, review and visualization, statistical analysis, tabulation, listing and graphs of clinical trial data
Excellent verbal and written communication skills; Leadership and team-ability with effective intercultural competences, diplomacy, negotiation and communication
Self-management skills with the ability to take initiatives, develop and evaluate alternative scenarios and options, and present them effectively to the colleagues and leadership of the company
Proficiency in MS Word, Excel, and PowerPoint software programs
Excellent problem-solving and strategic-thinking skills
Sound knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.)
Excellent written and oral communication and presentation skills
Ability to identify and address issues proactively in a timely manner
Ability to make appropriate, rational and well-justified decisions in ambiguous situations with incomplete or uncertain information; Ability to prioritize tasks and direct team accordingly
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.