Analyst, Statistical Programming

Posted 3 Days Ago
Be an Early Applicant
2 Locations
In-Office
81K-111K Annually
Junior
Biotech
The Role
Support and co-lead statistical programming for clinical studies: author and review ADaM specs, generate analysis datasets, tables/figures, and submission components (define.xml, XPT). Collaborate with Biostatistics and Data Management, oversee vendor deliverables, ensure regulatory compliance and standards (CDISC), and drive process improvements and study execution.
Summary Generated by Built In

This is a hybrid position that requires in-person weekly workdays at our offices in Durham, NC or in Cambridge, MA

About this role 

The 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 Information

The 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.


At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.


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. Biogen is an E-Verify Employer in the United States.



Skills Required

  • Bachelor's degree in Statistics, Mathematics, Computer Science or related STEAM field
  • Master's degree (preferred)
  • 2+ years relevant work experience in data management and analysis
  • 2+ years SAS Base programming using SAS/STAT, SAS/GRAPH and SAS Macro
  • 2+ years industry experience with clinical trials and clinical databases
  • CDISC and/or regulatory submissions experience
  • Some knowledge of drug development process and clinical trials
  • Some familiarity with UNIX and software development packages (R, imaging and genomics software)
  • Some familiarity with AI and ML concepts
  • Experience working in early phase studies (phase I, first-in-human, HV etc.)
  • Experience with PK/PD analyses (NCA, WinNonlin, PopPK, NONMEM)
  • Some knowledge of submission requirements and ICH/FDA/EMEA/ROW guidelines

Biogen Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Biogen and has not been reviewed or approved by Biogen.

  • Fair & Transparent Compensation Pay is generally positioned as competitive and often perceived as fair across roles, with total compensation framed as strong when bonus and equity are included. Compensation sentiment is described as above-average overall, though it varies by function and business cycle.
  • Equity Value & Accessibility Equity programs are repeatedly highlighted as a meaningful part of the total package, including stock programs and an employee stock purchase plan. Equity and bonus elements are portrayed as important contributors to feeling well rewarded beyond base pay.
  • Leave & Time Off Breadth Time-off benefits are described as distinctive, including a year-end shutdown and a paid sabbatical after extended tenure. Vacation, holidays, sick time, and personal-significance days are also presented as supportive of work-life needs.

Biogen Insights

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The Company
HQ: Cambridge, MA
9,575 Employees
Year Founded: 1978

What We Do

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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