Senior Director, Biostatistics

Company Profile:

At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused in our efforts to establish avutometinib + defactinib as the backbone of therapy for RAS-mediated tumors. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. We partner with global leaders (and their teams!) and these relationships help us to serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more at www.verastem.com.

Summary:

We are excited to add a senior member to the Verastem Oncology biostatistics team!  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

• Support regulatory submissions as needed including leading biostatistics and programming activities; provide response to regulatory requests independently; ensure applicable understanding of team members of statistical aspects of regulatory interactions

• Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections 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

• 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

• 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

Note: Please be advised that we are not accepting inquiries from recruiters at this time. Thank you for your understanding.