Associate Director, Statistical Programming

Summary

Join Biogen's West Coast Hub as an Associate Director, Statistical Programming, reporting to the Statistical Programming & Clinical Data Sciences Lead. Lead and oversee statistical programming activities internally and externally. Manage a team of statistical programmers, ensuring adherence to company SOPs and ICH/GCP. Develop and implement standard programming practices across programs/therapeutic areas. This role requires extensive experience in statistical programming, data management, and clinical trials within the pharmaceutical/biotech industry. Biogen offers a competitive salary and a comprehensive benefits package.

Requirements

• 15+ years relevant work experience within an organization with a focus on data management and analysis
• 15+ years SAS Base programming, with 7+ years using SAS STAT, GRAPH and MACRO
• 15+ years relevant pharma/biotech industry experience
• 15+ years clinical trial experience
• 10+ years clinical database experience
• CDISC and/or submissions experience
• Extensive knowledge of drug development process and clinical trials
• Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
• Familiarity with UNIX
• Strong management skills, and ability to effectively lead and collaborate with all functions
• High attention to detail including proven ability to manage multiple, competing priorities

Responsibilities

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight
• Provides statistical programming expertise within Biogen, including demonstrated proficiency in CDISC SDTM (Study Data Tabulation Model) and CDISC ADaM (Analysis Dataset model) implementation. Authors analysis data set specifications including the identification of potential data issues or areas of critical data examination. Engages with Biostatistics to define and document programming endpoint algorithms
• Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (eSUB) components (input to reviewer’s guides, annotated CRF, define and XPTs); works with SMEs in SSM to ensure compliance to eSUB standards
• Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT
• Serves as the Statistical Programming Lead to achieve milestones for an indication of a drug program/Therapeutic Area; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs
• Verifies 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
• Aligns internal and external project team members on statistical programming requirements, deliverable status, and resource needs

Preferred Qualifications

Experience with R

Benefits

• Medical, dental, life, long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions
• LTI grants
• Other incentive programs