Sr. Analyst, Statistical Programming
Biogen
4 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Hybrid: in-person workdays at facilities in Cambridge, MA.
Responsibilities:
- Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
- Author CDISC ADaM analysis dataset specifications, including identifying potential data issues and critical data examination areas; define and document programming endpoint algorithms across a study/drug program and contribute to TA-level algorithms.
- Manage end-to-end programming from CRF (Case Report Form) collections through electronic submission, including preparation of electronic submission components; work with SMEs to ensure compliance to submission standards.
- Serve as Statistical Programming Lead to achieve study milestones; collaborate with Portfolio Lead (PL) and/or manager on issues and resource needs.
- Verify program consistency and usage of data, analysis, and submission standards in consultation with data standards, statistical submissions management, and the data strategy plan.
- Inform internal and external project team members of programming requirements, deliverable status, and resource needs.
- Partner with Biostatistics to deliver submission-ready statistical outputs; provide some supervision.
- Provide PL input on study timeline, monitor milestones, escalate issues, and estimate resource needs; lead a study team of statistical programmers and oversee vendor quality/communication.
- Help implement the Data Strategy and provide input to Data Strategy Lead and DM lead to ensure appropriate statistical programming standards; develop and implement standard programming practices.
Qualifications:
- Bachelor’s degree required.
- 5+ years relevant work experience in data management and analysis.
- 5+ years SAS Base programming; 5+ years using SAS STAT, GRAPH, and MACRO.
- 5+ years relevant industry experience.
- 5+ years clinical trial experience.
- 3+ years clinical database experience.
- CDISC and/or submissions experience.
- Knowledge of drug development process, clinical trials, and drug submission requirements (ICH and FDA/EMEA/ROW guidelines).
- Some familiarity with UNIX and software development packages (R, Imaging, Genomics).
Benefits (as stated):
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs (fitness reimbursement); short- and long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days; sick time (80 hours/year); paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
Compensation (as stated): $100,000.00–$130,000.00 base range.
Responsibilities:
- Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
- Author CDISC ADaM analysis dataset specifications, including identifying potential data issues and critical data examination areas; define and document programming endpoint algorithms across a study/drug program and contribute to TA-level algorithms.
- Manage end-to-end programming from CRF (Case Report Form) collections through electronic submission, including preparation of electronic submission components; work with SMEs to ensure compliance to submission standards.
- Serve as Statistical Programming Lead to achieve study milestones; collaborate with Portfolio Lead (PL) and/or manager on issues and resource needs.
- Verify program consistency and usage of data, analysis, and submission standards in consultation with data standards, statistical submissions management, and the data strategy plan.
- Inform internal and external project team members of programming requirements, deliverable status, and resource needs.
- Partner with Biostatistics to deliver submission-ready statistical outputs; provide some supervision.
- Provide PL input on study timeline, monitor milestones, escalate issues, and estimate resource needs; lead a study team of statistical programmers and oversee vendor quality/communication.
- Help implement the Data Strategy and provide input to Data Strategy Lead and DM lead to ensure appropriate statistical programming standards; develop and implement standard programming practices.
Qualifications:
- Bachelor’s degree required.
- 5+ years relevant work experience in data management and analysis.
- 5+ years SAS Base programming; 5+ years using SAS STAT, GRAPH, and MACRO.
- 5+ years relevant industry experience.
- 5+ years clinical trial experience.
- 3+ years clinical database experience.
- CDISC and/or submissions experience.
- Knowledge of drug development process, clinical trials, and drug submission requirements (ICH and FDA/EMEA/ROW guidelines).
- Some familiarity with UNIX and software development packages (R, Imaging, Genomics).
Benefits (as stated):
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs (fitness reimbursement); short- and long-term disability; paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days; sick time (80 hours/year); paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
Compensation (as stated): $100,000.00–$130,000.00 base range.