This role will be responsible for overseeing statistical activities for multiple clinical studies within a clinical development program, serve as a key contributor to study design and protocol development, and conceptualizing and performing analyses of clinical trial data. This is a hands-on position, and the individual will participate in a variety of strategic departmental initiatives as well as cross functional technology development and process improvement initiatives.
Responsibilities:
- Serve as a biostatistics leader within the organization, and manage statistical efforts for multiple clinical studies across a clinical program; provide leadership and guidance to other members of biostatistics and statistical programming team
- Formulate, carry out, and oversee statistical analyses of clinical trial data to advance clinical development programs and to facilitate external collaborations; communicate interpretation of results cross-functionally
- Lead regulatory submissions as needed including from a biostatistics and programming activities perspective; provide response to regulatory requests independently; ensure applicable understanding of team members of statistical aspects of regulatory interactions
- Author protocol sections on statistical methods and review/edit other sections including (but not limited to) endpoints, objectives and assessments, by applying statistical principles
- Author or oversee creation of statistical analysis plans for studies and/or ISS/ISEs; author/edit shells for tables, figures and listings
- Provide statistical input to independent data monitoring committee (IDMC) and independent review committee (IRC) charters, project management plan, and other study-level documents
- Create and manage timelines for SAPs, analysis specifications, and IDMC documents as needed by project/study teams
- Conduct statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
- Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses; review and approve programming specifications for SDTM and ADaM datasets, pre-specified TLFs and ad-hoc analyses
- Support ongoing safety review and IDMC review of the clinical development program/study teams
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
- Support the preparation of publications, including manuscripts, posters and oral presentations
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
Qualifications:
- PhD in statistics or a related field with at least 8 years of relevant clinical trial experience or MS in statistics or equivalent with at least 11 years of relevant clinical trial experience
- Knowledge of statistical methods for clinical trials
- In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
- Experience with NDAs, MAAs and other regulatory submissions is a plus
- Proficient in statistical programming (SAS is required and R is a plus)
- Experience with clinical trial design
- Good communication skills and ability to work with cross-functional study teams
- Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Good analytical and problem solving skills
- Positive and collaborative attitude
- Oncology clinical trial experience preferred
The base salary range ($250,000 - $300,000) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
