Principal Analyst, Statistical Programming
Biogen
2 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Principal Analyst, Statistical Programming
Responsibilities:
- Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
- Author CDISC ADaM analysis dataset specifications, identifying potential data issues and critical data examination areas; define/document programming endpoint algorithms across a study, drug program, and/or therapeutic area level.
- Manage end-to-end programming from CRF collections through electronic submission, including preparation of submission components; partner with SMEs to ensure compliance with submission standards.
- Serve as Statistical Programming Lead to achieve study milestones; collaborate with Portfolio Lead/manager on issues and resource needs.
- Verify program consistency and usage of data, analysis, and submission standards within a study.
- Provide input to the Data Strategy effort and support strategic direction with Data Strategy Lead and DM Lead; develop and implement standard programming practices across a study.
- Inform internal and external project team members of programming requirements, deliverable status, and resource needs; provide vendor communication and quality oversight.
Qualifications:
- Bachelor’s degree required; Master’s or PhD in Statistics or Mathematics preferred.
- 7+ years relevant work experience focused on data management and analysis.
Required Skills/Experience:
- 7+ years SAS Base programming, including 7+ years 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 and ICH and FDA/EMEA/ROW guidelines.
- Familiarity with UNIX and software development packages (R, imaging, genomics).
- Familiarity with AI and ML concepts.
Benefits:
- Medical, dental, vision, and life insurance; fitness/wellness programs with fitness reimbursement; short- and long-term disability insurance.
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal days; 80 hours sick time/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.
Responsibilities:
- Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
- Author CDISC ADaM analysis dataset specifications, identifying potential data issues and critical data examination areas; define/document programming endpoint algorithms across a study, drug program, and/or therapeutic area level.
- Manage end-to-end programming from CRF collections through electronic submission, including preparation of submission components; partner with SMEs to ensure compliance with submission standards.
- Serve as Statistical Programming Lead to achieve study milestones; collaborate with Portfolio Lead/manager on issues and resource needs.
- Verify program consistency and usage of data, analysis, and submission standards within a study.
- Provide input to the Data Strategy effort and support strategic direction with Data Strategy Lead and DM Lead; develop and implement standard programming practices across a study.
- Inform internal and external project team members of programming requirements, deliverable status, and resource needs; provide vendor communication and quality oversight.
Qualifications:
- Bachelor’s degree required; Master’s or PhD in Statistics or Mathematics preferred.
- 7+ years relevant work experience focused on data management and analysis.
Required Skills/Experience:
- 7+ years SAS Base programming, including 7+ years 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 and ICH and FDA/EMEA/ROW guidelines.
- Familiarity with UNIX and software development packages (R, imaging, genomics).
- Familiarity with AI and ML concepts.
Benefits:
- Medical, dental, vision, and life insurance; fitness/wellness programs with fitness reimbursement; short- and long-term disability insurance.
- Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal days; 80 hours sick time/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.