System One Director, Biostatistics in Cambridge, Massachusetts
Director Biostatistics, 100% remote
You will play a key role in building a truly modern clinical development organization. You will carry out statistical activities in support of our innovative clinical trials. You will develop Statistical Analysis Plans (SAP) and create table, listing and figure shells, and review Case Report forms (CRFs/eCRFs), all the while considering how we can improve these processes. You will perform statistical analysis as defined in the SAP, plan the design and analysis for our clinical trials, provide statistical input to clinical study reports, and provide statistical support to drug safety, medical affairs and pharmacology.
The biostatistician will be an integral part of the clinical development team at all steps of development, from study design to approval, and will be encouraged to think outside the box to accelerate approval, both when developing our core processes and in developing our clinical study plans.
Responsibilities and Qualifications:
PhD degree in biostatistics or statistics, with at least 8 years (PhD) of directly related experience in the pharmaceutical industry, in Oncology
Led regulatory submissions with experience working in the Oncology
Strong understanding of drug development processes and regulatory requirements, including ICH/GCP guidelines
Expertise in using statistical programming software (e.g., SAS, R)
Expert communicator and are adept at explaining complex topics to stakeholders with a variety of non-technical backgrounds
Participate and work effectively on multiple cross-functional teams.
Strong interpersonal skills - you understand relationships are key and are a team player who is willing to roll-up your sleeves and get the job done
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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