Temporary Biostatistician - Early Clinical Development

Location
Tarrytown, New York, US
Posted
Nov 20, 2018
Ref
14076BR
Required Education
Doctorate/PHD/MD
Position Type
Contract
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 . Summary . The Biostatistics and Data Management group is looking for a Biostatistician to support Early Clinical Development and Exploratory Sciences. This position is for a qualified statistician with experience in the pharmaceutical/biotechnology sector, to collaborate in cross-functional drug development teams to execute innovative development strategies for compounds entering early clinical development . Duties . The incumbent will work under the direct supervision of permanent statisticians, to work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate the requisite data and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. The incumbent will work with more experienced project statisticians to co-author clinical study protocols, co-author statistical analysis plans, and perform statistical analyses for interim and final reports . Under direct supervision and guidance of senior departmental staff, provide support to a clinical study team on all relevant statistical matters. As member of study team, ensure the clinical study is conducted in a manner that supports planned statistical analysis . Under supervision and guidance of senior departmental staff, participate in preparation of study protocol and amendments. Perform relevant sample size calculations and write statistical methodology section of the protocol . Review case report form CRF and provide comments and feedback . Develop statistical analysis plan SAP . Provide programming team with definitions and documentation for derived variables needed to produce planned Tables, Figures and Listings TFLs . Develop data and programming specifications jointly with programmers . Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, prepare statistical methods and results sections for the clinical study report CSR , provide statistical insight into interpretation and discussion of study results, and work with the study team to move the CSR through review /approval process . Requirements . PhD or equivalent degree in statistics/biostatistics or related disciplines OR MS with 3 years relevant work experience . Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies . Strong influence and leadership skills, with a track record of collaboration with scientists and researchers at Biostatistician level . Solid knowledge of statistical analysis methodologies, experimental and clinical trial design . Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, and effective communication and presentation skills . Expertise in statistical software, such as R, SAS, WinBUGS, STAN, and/or Matlab is required. Preferred . Experience with linear and nonlinear models, Bayesian methodology, statistical decision theory, modeling and simulation, and model-informed drug development . Experience in clinical pharmacology studies, pharmacokinetics PK , and PK/PD modeling . 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, biostatistician, statistician, Biostat, STAt