Principal Analyst, Statistical Programming jobs in United States
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Biogen · 18 hours ago

Principal Analyst, Statistical Programming

positionSan Francisco, CA
timeFull-time
remoteHybrid
senioritySenior Level, Lead/Staff
money$122K/yr - $163K/yr
date7+ years exp

Biogen is a mid-sized biotechnology company committed to excellence and innovation. They are seeking a Principal Analyst in Statistical Programming to lead and oversee statistical programming activities, ensuring high-quality outputs and compliance with standards.

BiotechnologyHealth CareNeuroscienceTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight
Authors CDISC ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination
Manage the end-to-end programming of deliverables through from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs), works with SMEs to ensure compliance to eSUB standards
Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes
Serves as the Statistical Programming Lead to achieve milestones for a study; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs
Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan
Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs

Qualification

SAS Base programmingCDISC ADaM specificationsClinical trial experiencePharmaceutical/biotech experienceR ProgrammingDrug development knowledgeUNIX familiarityManagement skillsAttention to detailCollaboration

Required

7+ years relevant work experience within an organization with a focus on data management and analysis
7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
7+ years relevant pharmaceutical/biotech 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, relevant ICH and FDA/EMEA/ROW guidelines
Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
Management skills, and ability to effectively lead and collaborate across functions
Attention to detail including proven ability to manage some competing priorities

Preferred

Experience with ISS/ISE and NDA/BLA submission
R Programming skill

Benefits

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

Company

Biogen

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Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
dateFounded in 1978
location
Cambridge, Massachusetts, USA
people-size5001-10000 employees
web-link
https://www.biogen.com/en_us/home.html

H1B Sponsorship

Biogen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)

Funding

Current Stage
Public Company
Total Funding
$1.5B
Key Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO

Leadership Team

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Robin C. Kramer
Executive Vice President, Chief Financial Officer
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Priya Singhal
Executive Vice President, Head of Development
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