What are the responsibilities and job description for the Senior Biostatistician position at Actalent?
RESPONSIBILITIES:
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
Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data
Review and/or write the statistical and results sections of clinical study reports
Review and/or assist in writing publications
Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
Manage multiple projects
Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review
Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis
Support proposal development and attend bid defense meetings
Review Request for Proposal (RFP) and Scope of Work (SOW) documents
Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks
Manage project budget and forecast resources needed for studies
Additional responsibilities as assigned by supervisor/manager
EDUCATION
Master’s degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline required
PhD degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferred
EXPERIENCE
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
SKILLS
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
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
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $140,000 - $160,000
