Sr. Manager/Associate Director, Biostatistics

---

Job description

Primary Responsibilities

• Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR)


• Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups


• Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others.


• Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities.


• Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected.


• Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.

Requirements

• Master'sin Biostatistics or statistics or applied mathematics


• At least 3 years of pharmaceutical clinical trial experience


• In-depth knowledge of clinical trials methodology, regulatory requirements, statistics


• Comprehensive experience of SAS programming and R/S language


• Experience in oncology trials preferred


• Ability to effectively collaborate in a dynamic environment


• Excellent practical, organizational, interpersonal, oral and written communication skills are a must.

Additional

• We are open to providing relocation for this position

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)