Associate Director, Biostatistics

Job Description

The Associate Director of Biostatistics is responsible for leading complex or integrated study design and data analysis in clinical development. He/She act as RDPT Biostatistician, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports and regulatory documents with high quality. He/she builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework. He/She provides responses to statistical issues arising in regulatory, other legal settings, or external development partners. He/She provides mentorship to new/junior biostatisticians. He/She also contributes to the long-term growth strategy of the department by participating in process improvement initiatives and keeping up to date of and contributes to the current statistical methodology development. 

Principal Accountabilities

1. Key player in the strategic planning and execution of the clinical development plan for the assigned project; provides strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, NDAs and MAAs.
2. Manages assigned staff and FSPs statisticians to ensure quality and consistency of the deliverables; provides guidance and support to facilitate their development and enhanced efficiency; provides regular feedback to staff and management. 
3. Provides key strategic contributions in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs as required.
4. Serves as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, CSRs, regulatory documents, and manuscripts), and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
5. Participates in approved process improvement initiatives; keeps up to date on current statistical methodology development and regulatory environment

Qualifications

Who You Are: 

You are an experienced biostatistician with a thorough understanding of statistical principles and clinical trial design/methods and with experience in submission or responding to regulatory questions and with proven ability to develop creative statistical/technical/regulatory acceptable solutions to complex problems in the design/analyses of clinical trials. You have leadership skills in effective communication, proactive strategy thinking, priority evaluations, and team working. 

• PhD in Biostatistics/Statistics or equivalent with a preferred 6+ years relevant work experience or …