Sr. Director Biostatistics

In this hands-on position reporting to the Vice President of Biostatistics, you will apply your technical expertise and experience to provide recommendations on statistical design and conduct of clinical trials of all phases. You will use your initiative to develop, maintain and share knowledge of appropriate statistical methods for data analysis and clinical trial design, and work collaboratively across disciplines with clinicians, statistical programmers, data managers, and medical writers in the planning, conduct and analysis of clinical trials.  

This role is based out of our San Francisco, CA or Cambridge, MA office and will require 10%travel. 

Your work will primarily encompass: 

• Serve as biostatistics lead in designing clinical trials and leading data analyses
• Apply innovative approaches to study design, analysis methodologies, data exploration, and presentation
• Provide statistical inputs to protocols, data monitoring committee (DMC) charters, clinical study reports (CSR) and other study-level documents, in collaboration with the study team
• Author relevant sections of regulatory submissions, documents, responses, and address comments by IRB/ECs
• Author statistical analysis plan, TLF shells and table of contents for outputs to be generated
• Accountability for statistical activities in support of regulatory submissions/interactions
• Collaborate with multi-functional groups on IB, DSUR, CSR, integrated efficacy/safety summaries, external presentations, and publications
• Review ADaM specifications and verify primary and key secondary efficacy endpoints
• Oversee programming of ADaMs and TLFs for the study 
• Validate/QC key study endpoint analysis and submission deliverables 
• Effectively manage CRO to ensure high-quality deliverables within timeline and budget 
• Review CRFs, CRF edit checks, CRF completion guidelines, and data management plan 
• Responsible for one or more studies with concurrent tasks and timelines 

Ideal Candidate Profile  >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Knowledge of appropriate regulations, industry standards and guidance documents 
• Broad and thorough understanding of statistical principles and clinical trial methodology; ability to practice and implement statistical principles and methodology 
• Ability to interact effectively with biostatistical, data management, operations, and clinical personnel internally and from CROs 
• Knowledge of CDISC and SDTM/ADaM specifications 
• Strong SAS programming skill  
• Able to guide the successful completion of major programs and projects 
• Strong analytical and communication skills 
• Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies 

Experience: 

• 8+ years (with PhD degree) or 10+ years (with master's degree) in biotech/pharmaceutical industry
• Late-stage development experience in oncology (design and execution of registrational phase 3 studies)
• Experience in interactions with regulatory agencies; prior record of regulatory submissions and approvals in oncology is preferred
• Experience in management of CROs with respect to conduct and analysis of clinical trials
• Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework
• Leading or managing the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing   
• Utilizing broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways 

Attributes: 

• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflict resolution, and effective partnerships 
• Statistical expertise and experience in managing the activities of clinical trials  
• Ability to develop innovative/creative statistical and technical solutions to complex problems 
• Strong verbal and written communication skills 
• Ability to effectively represent Biostatistics in multidisciplinary meetings 
• A commitment to excellence  
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
• Have impeccable professional ethics, integrity and judgment

The base pay range for this position is expected to be $240,000-$297,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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