Senior Director, Biostatistics

Overview of Role:

This position serves as the project level biostatistician providing technical leadership and statistical expertise to the design and execution of late-stage oncology clinical trials. They will contribute to protocol development, author the statistical analysis plans, conduct statistical analyses, and oversee biometrics activities for regulatory submissions. This position will collaborate with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. The Senior Director will develop and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. They will represent biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.  

Role and Responsibilities:

• Provide technical leadership and statistical expertise in the design and execution of late-stage oncology clinical trials 

• Contribute to protocol development, ensuring trial design, sample size, and statistical methodologies are appropriate and efficient 

• Lead the development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses 

• Review clinical data for accuracy, perform statistical analyses, interpret study results, and collaborate with cross functional teams to produce interim and final reports, as well as publications 

• Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes 

• Review vendor data transfer specifications and ADaM programming specifications 

• Lead assessment and introduction of novel statistical methodologies to implement solutions 

• Represent biostatistics function or biometrics department in cross function teams 

• Work with department leader to develop and implement department policies, standards and procedures 

• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan 

• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets 

• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success 

• Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development 

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Ph.D. in Statistics, Biostatistics or a related field with 12+ years biopharmaceutical industry experience required. An MS degree in a related discipline with extensive industry and leadership experience (15+ years) may also be considered. 

• 5+ years of experience in oncology clinical trials, including trial design and execution, with a strong background in late-stage clinical trials

• Deep understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)

• Experience providing statistical support for Medical Affairs and Market Access activities is highly preferred

• Experience interacting with health authorities 

• Technical expertise in statistical methodology and strong programming skills with SAS or R 

• Excellent written and verbal communication skills and organizational skills 

• Good working knowledge of ICH, FDA and GCP regulations and guidelines 

• Attention to detail, accuracy and confidentiality 

• Critical thinking, problem-solving abilities, and capacity to work independently

• Must be able to effectively multi-task, manage time-sensitive and highly confidential documents, and prioritize conflicting demands

• Comfortable working in a fast-paced, demanding and collaborative environment