Statistical programmer Jobs in Wilmington, NC

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About this role

The Senior 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 youll 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 endtoend 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 a Senior Analyst with strong statistical programming skills who pays close attention to detail and have the proven ability to manage some competing priorities.

Qualifications : Required Skills :

Preferred Skills :

Additional Information :

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 DE&I efforts.

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 EVerify Employer in the United States.

Remote Work : Employment Type :

Fulltime