||Aug 09, 2019
||3 yrs- 5 yrs
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Principal Biostatistician assumes responsibility for methodological and statistical aspects of a project or group of clinical studies, with general direction from Therapeutic Area lead biostatistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases incumbent could serve as technical expert in a particular statistical area or application.
Work with the clinical and regulatory functions to define study endpoints and perform relevant sample size calculations. Develop statistical analysis plan (SAP)
• With general guidance from senior departmental staff, assume leadership role for providing statistical support to one or more study teams on all relevant statistical matters. Act as direct liaison to the study team or provide guidance to a junior staff member filling this role
• Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variablesExpertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis
• Oversee execution of the statistical analysis according to the SAP and preparation of the statistical methods and results sections for the clinical study report (CSR). Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results
• Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or to independent monitoring committees. Review submission documents, such as IND, BLA, or CTD to insure statistical validity and accuracyresponse to Health Authorities from other countries
Collaborate with project team on the production of the clinical development plan (CDP). Work with senior departmental staff to develop statistical position on key study or project issues. May act as representative to extended project team.
Provide significant input to Therapeutic Area lead biostatistician on project activity and timeline tracking, resource planning, and preparation of scientific reports or position papers.
PhD + 0 year experience or MS + 6 yrs biotech / pharma experience in statistics or related discipline with 6+ (8+) years of experience in the pharmaceutical for Phase II, III and IV
Knowledge of pharmaceutical / biotech clinical development
o Ability to use statistical methods to assess/improve efficiency and effectiveness in drug development
o Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis
o Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, e.g., CTD guidance, ICH guidelines
o Support NDA/sDNA submission and in response to FDA queries. EMA type II submission experience and in response to Health Authorities from other countries
o Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in one or more therapeutic areas / indications
o Familiarity and practical experience in design, production, and use of submission-quality electronic datasets.
o Ability to define and meet study / project timelines for deliverables such as protocol, clinical study summaries, and key analyses
o Strong communication skills, experience managing internal team, extensive leadership skills and extensive outsourcing project managing experience with CROs.
o Ability to organize, lead, and motivate teams.
SAS, S-Plus/R, Sample size calculation software (e.g., EAST and Nquery)
May report to a Assoca. Director or above
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
LMR, #LI-LR1, principal statistician, manager statistician,