Description:

　　• Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios

　　• Perform sample size calculations and write statistical methodology sections for inclusion in study protocols

　　• Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents

　　• Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions

　　• Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable

　　• Develop SAS programs to produce and/or QC statistical tables/figures/data listings

　　• Perform mapping from raw datasets to CDISC SDTM datasets

　　• Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission

　　Skills:

　　Biostatistics, Statistics, Sas, Clinical trial, Clinical research, CRO, oncology, rare disease, Sas programming

　　Additional Skills & Qualifications:

　　• Minimum of 5 years of experience in statistical analysis of clinical trials data or

　　• Minimum of 3 years of experience in statistical analysis of clinical trials data if relevant PhD degree has been obtained

　　• Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods

　　• Proficiency in SAS statistical programming

　　• Knowledge of other statistical and data management software packages is a plus

　　• Strong written and oral communication skills

　　• Knowledge and experience with CDISC data standards and models

　　• Strong project management and mentoring/leadership skills

　　• In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

　　• Ability to effectively manage multiple tasks and projects

　　• Ability to clearly describe statistical techniques and interpret results

　　• CRO experience required

　　• JD says 3-5 but it’s more like 9-10 years ideally

　　• Cdisc experience is a must and ADaM data sets

　　• SAS programming experience

　　• Oncology/rare disease experience

　　About Actalent

　　Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

　　If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.