Sr. Principal Analyst, Statistical Programming

About This Role

The Senior Principal Analyst, Statistical Programming reports to the Statistical Programming Manager, West Coast Hub, Biogen. He/She will lead and oversee statistical programming activities of internal and external vendors at study or project level, ensuring all deliverables adhere to company SOPs and ICH/GCP. The position also supports the Data Strategy, develops and implements standard programming practices, and ensures their adoption across studies or programs.

• Lead, coordinate and manage the timely creation, oversight, review, completion and delivery of statistical programming activities and deliverables for study projects via internal and/or external staff oversight.
• Serve as the Statistical Programming Lead to achieve milestones for drug programs, including individual studies or integrated studies; evaluate task objectives and collaborate with PLs or managers on issues or resource needs.
• Manage the end-to-end programming of deliverables from CRF collections through electronic submission, including preparation of eSUB components (input to reviewer’s guides, annotated CRF, define, and XPT files); work with SMEs in DS&G to ensure compliance with eSUB standards.
• Inform internal and external project team members of statistical programming requirements, deliverable status and resource needs.
• Author CDISC ADaM analysis dataset specifications, identify potential data issues or areas requiring critical examination, and document programming endpoint algorithms across studies, drug programs or TA-level algorithms.
• Identify process inefficiencies and lead efforts to remediate them; train the department on new processes in conjunction with QPT.
• Verify program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan.

• Bachelor’s degree required, Master’s or PhD in Statistics or Mathematics preferred.
• 10 years of relevant work experience within an organization focusing on data management and analysis.
• 10+ years SAS Base programming experience and 7+ years using SAS STAT, GRAPH and MACRO.
• 10+ years of relevant industry experience, including 10+ years clinical trial experience and 5+ years clinical database experience.
• Experience with CDISC and submissions.
• Extensive knowledge of drug development process and clinical trials.
• Extensive knowledge of drug submission requirements, ICH and FDA/EMEA/ROW guidelines.
• Familiarity with UNIX.
• Strong management skills and ability to lead and collaborate across functions.
• High attention to detail and proven ability to manage multiple, competing priorities.

• Experience with ISS/ISE and NDA/BLA submissions.
• Experience with Clinical Trial Efficacy, PK/PD and/or biomarkers.

Management

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.