This is a
hybrid position that requires in-person weekly workdays at our offices in
Durham, NC or in
Cambridge, MAAbout this roleThe Analyst, Statistical Programming supports statistical programming activities across clinical development programs, partnering with Biostatistics, Data Management, and external vendors to deliver high-quality, submission-ready statistical outputs. This role contributes to analysis datasets, specifications, tables, listings, figures, electronic submission components, and ad hoc analyses while ensuring compliance with data and programming standards. The position also helps drive study execution, process improvement, and implementation of Biogen's data strategy.
What you'll do - Co-lead, under supervision, the planning, coordination, oversight, review, completion, and delivery of statistical programming activities and study deliverables.
- Author and review CDISC ADaM analysis dataset specifications and identify potential data quality concerns.
- Collaborate with statisticians to define, document, and implement endpoint programming algorithms.
- Manage end-to-end programming activities from CRF collection through electronic submissions, including define.xml and XPT deliverables.
- Partner with submission and standards teams to ensure regulatory compliance and quality.
- Support continuous improvement initiatives that enhance programming processes and efficiency.
- Serve as the Statistical Programming co-lead for assigned studies and communicate resource needs, risks, and issues.
- Provide oversight and quality review of vendor programming activities and deliverables.
- Ensure consistent implementation of analysis, data, and submission standards across studies.
Who you are You are a detail-oriented statistical programming professional with strong analytical and programming capabilities. You thrive in a collaborative environment, effectively manage competing priorities, and contribute to delivering high-quality clinical trial data and analyses. You embrace Biogen's culture of pioneering, thinking broadly, driving results, and fostering an ethical and inclusive workplace.
Required skills - Bachelor's degree required and Masters preferred in Statistics, Mathematics, Computer Science or other related STEAM fields.
- 2+ years' relevant work experience within an organization with a focus on data management and analysis
- 2+ years SAS Base programming using SAS STAT, GRAPH and MACRO
- 2+ years relevant experience from industry, on clinical trial and clinical database.
- CDISC and/or submissions experience
- Some knowledge of drug development process and clinical trials.
- Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
- Some familiarity AI and ML concepts
Preferred skills - Experience working in early phase studies (phase I, first-in-human, HV etc.)
- Experience from PK/PD analyses (NCA, WinNonLin, PopPK, NONMEM etc.)
- Some knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.
Job Level: Professional
Additional InformationThe base compensation range for this role is: $81,000.00-$111,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Job Level: Professional
Additional InformationThe base compensation range for this role is: $81,000.00-$111,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
