Sr Principal Analyst, Statistical Programming

Biogen, Inc.; San Francisco (CA); Presencial; USD 141.000 - 188.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision, & Life insur.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

Holidays + Personal days

Sick time

Parental Leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Descripción de la vacante

Biogen, Inc. in San Francisco seeks a Senior Principal Analyst, Statistical Programming to lead programming across studies and vendors, ensuring timely, high-quality outputs aligned with regulatory standards.

You will develop ADaM specs, support analyses with Biostatistics, and manage deliverables from database build to submissions in a fast-paced environment.

Formación

• Bachelor’s degree required; Master’s or PhD in Statistics, Mathematics, Biostatistics, or related quantitative field preferred.
• 10+ years of pharmaceutical/biotech/CRO experience with clinical data analysis and statistical programming.
• 10+ years SAS programming experience including Base SAS; 7+ years SAS STAT, SAS Macro, and SAS Graph.
• 10+ years experience supporting clinical trials across multiple phases of drug development.
• 5+ years working with clinical databases and clinical data structures.
• Demonstrated expertise in CDISC standards (SDTM/ADaM) and regulatory submission deliverables.
• Strong understanding of the drug development lifecycle and regulatory submission requirements (ICH/FDA/EMA).
• UNIX/Linux background and ability to work in cross-functional teams.

Responsabilidades

• Lead and oversee statistical programming across studies or programs, coordinating internal teams and external vendors.
• Serve as the Statistical Programming Lead for one or more clinical programs, driving milestones and addressing challenges.
• Manage programming deliverables from database build through regulatory submission (define.xml, annotated CRFs, reviewer guides, transport files).
• Partner with cross-functional stakeholders to communicate requirements, status, risks, and resource needs.
• Develop ADaM specifications, support analyses, and collaborate with Biostatistics on endpoints and analyses.
• Identify opportunities to improve programming processes, standards, and efficiencies.
• Ensure consistency and compliance with data, analysis, CDISC, and regulatory submission standards.

Conocimientos

Base SAS

SAS STAT

SAS Macro

SAS Graph

CDISC SDTM

CDISC ADaM

Regulatory submission

UNIX/Linux

Leadership

Vendor management

Project management

eSub

Educación

Bachelor’s degree

Master’s or PhD in Statistics/Math/Biostatistics

Herramientas

eSub

UNIX/Linux

Descripción del empleo

About This Role

The Senior Principal Analyst, Statistical Programming reports to the Head of Statistical Programming, West Coast Hub, and provides leadership and oversight of statistical programming activities across internal teams and external vendors at both the study and program levels. This role ensures the timely delivery of high-quality programming outputs in compliance with company SOPs, ICH/GCP guidelines, and regulatory requirements, while driving the implementation of data strategy initiatives and standardized programming practices across studies and development programs.

What You’ll Do

• Lead and oversee statistical programming activities across studies or programs, including coordinating internal teams and external vendors to ensure timely, high-quality deliverables.
• Serve as the Statistical Programming Lead for one or more clinical programs, driving key milestones, managing priorities, and addressing resource or project challenges.
• Manage programming deliverables from database build through regulatory submission, including experience with eSub components such as define.xml, annotated CRFs, reviewer guides, and transport files.
• Partner with cross-functional stakeholders to communicate programming requirements, project status, risks, and resource needs.
• Develop ADaM specifications, support statistical analyses, and collaborate with Biostatistics to define and implement endpoint derivations and analysis algorithms.
• Identify opportunities to improve programming processes, standards, and efficiencies, and help drive adoption of best practices across teams.
• Ensure consistency and compliance with data, analysis, CDISC, and regulatory submission standards across studies and programs.

Who You Are

You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration.

Required Skills

• Bachelor’s degree required; Master’s or PhD in Statistics, Mathematics, Biostatistics, or a related quantitative field preferred.
• 10+ years of pharmaceutical, biotechnology, or CRO industry experience with a focus on clinical data analysis and statistical programming.
• 10+ years of hands‑on SAS programming experience, including extensive use of Base SAS; 7+ years utilizing SAS STAT, SAS Macro, and SAS Graph.
• 10+ years of experience supporting clinical trials across multiple phases of drug development.
• 5+ years of experience working with clinical databases and clinical data structures.
• Demonstrated expertise in CDISC standards (SDTM and ADaM) and regulatory submission deliverables.
• Strong understanding of the drug development lifecycle, clinical trial processes, and industry best practices.
• In‑depth knowledge of global regulatory submission requirements, including ICH guidelines and FDA, EMA, and other international health authority standards.
• Working knowledge of UNIX/Linux environments.
• Proven leadership experience with the ability to effectively manage projects, oversee vendors, and collaborate across cross‑functional teams.
• Exceptional attention to detail, organizational skills, and the ability to prioritize and manage multiple concurrent initiatives in a fast‑paced environment.

Preferred Skills

• Experience with ISS/ISE development and NDA/BLA submissions
• Proficiency in R programming
• Experience working in a global regulatory environment

Job Level

Management

Additional Information

The base compensation range for this role is: $141,000.00-$188,250.00 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.

• 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 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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.