Biostatistician (Temporary)

Job Title Biostatistician- R45042 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 markets medicines for eye diseases, atopic dermatitis, asthma, COPD, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), oncology, hypercholesterolemia, and rare inflammatory conditions. Regeneron also has product candidates in development in other areas of high unmet medical need. Position Description The Biostatistician implements and executes methodological and statistical aspects of clinical studies under the supervision of Therapeutic Area lead biostatistician or project lead statistician. In some cases, principal function could be to develop/employ technical expertise in a particular statistical area or application. Roles Responsibilities

• 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.
• Support/participate in project related activities including preparation of BLA submissions and oversee CRO deliverables for studies contracted out.

Skills

• 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.
• Develop data and programming specifications jointly with programmers.
• Perform statistical analysis according to the SAP.
• Validate analysis programs and review TFLs.
• Prepare statistical methods and results sections for the CSR.
• Provide statistical insight into interpretation and discussion of study results.
• Support/participate in project related activities including preparation of BLA submissions.

Education & Experience

• Master Degree in related field required
• 2 years of relevant experience

This is a contract position at Regeneron in partnership with Agileone and Allsource as the Employer of Record. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Apply tot his job Apply To this Job