Co-lead (with supervision), coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
Co-author basic CDISC ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination. Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program
Participate in efforts to remedy departmental inefficiencies in conjunction with QPT.
Serve as the Statistical Programming co-lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.
Verify program consistency and usage of data, analysis and submission standards within a study in consultation with data standards, statistical submissions management, and the data strategy plan.
Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
Requirements
Required Skills:
Bachelor's degree required, Masters or PhD in Statistics or Mathematics preferred
2+ years relevant work experience within an organization with a focus on data management and analysis
2+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
2+ years relevant industry experience
2+ years clinical trial experience
2+ years clinical database experience
CDISC and/or submissions experience
Some knowledge of drug development process and clinical trials
Some knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
Some familiarity AI and ML concepts
Job Level: Professional
Additional Information
The base compensation range for this role is: $81,000.00-$105,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
This is a hybrid position requiring physical presence at our offices in the RTP, NC area.
About this role
The Analyst, Statistical Programming supports statistical programming activities (with assistance from project team lead or line management) internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. Partners with Biostatistics to deliver high quality, submission ready statistical outputs with supervision.
This Analyst is also responsible for providing input to the data management on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their line manager. Co-leads a small study team of statistical programmers to accomplish tasks, communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. Under supervision, he/she represents the Statistical Programming perspective to the study team and is often the sole functional representative.
The Analyst helps to implement the Data Strategy, provides input on the strategic direction of a study, partners with the Data Standard to ensure appropriate statistical programming standards implementation. Implements standard programming practices while also ensuring that they are employed across a small study. Collaborates with data management and statistics on tools and process improvement for Statistical Programming.
Biogen · Research Triangle Park, NC