Biogen
This is a hybrid role requiring weekly presence at our offices.
This position can be based in Durham, NC or Cambridge, MA
About this role
The Principal Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs. You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is often the sole functional representative. You will help to implement the Data Strategy, provide input to the Data Strategy Lead and DM lead on the strategic direction of the study to ensure appropriate statistical programming standards implementation and serve as reference for the study to the Data Sharing representative. You will develop and implement standard programming practices while also ensuring that they are employed across a study. You will collaborate with technical programming on tools and process improvement for Statistical Programming**.**
What you’ll do
Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
Authors CDISC (Clinical Data Interchange Standards Consortium) 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 and/or contributing to TA level algorithms.
Manages the end-to-end programming of deliverables from CRF (Case Report Form) collections through electronic submission including preparation of electronic submissions components; works with SMEs (Subject Matter Expert) to ensure compliance to submission standards.
Serves as the Statistical Programming Lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.
Verifies 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.
Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
Who you are
You are an analyst with strong statistical programming skills who pays close attention to detail and have the proven ability to manage some competing priorities.
Required Skills
Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
7+ years relevant work experience within an organization with a focus on data management and analysis
7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
7+ years relevant industry experience
7+ years clinical trial experience
5+ years clinical database experience
CDISC and/or submissions experience
Knowledge of drug development process and clinical trials
Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
Familiarity with AI and ML concepts
Job Level: Management
Additional Information
The base compensation range for this role is: $116,000.00-$163,000.00
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:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.