Senior Statistical Programmer - Lead, Clinical Submissions

Biogen, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Tuition reimbursement

401(k) with company match

Paid time off

Job summary

Biogen operates a hybrid role in the Cambridge/Durham area seeking a Senior Analyst, Statistical Programming to lead programming activities and oversee vendor work, delivering submission-ready outputs with minimal supervision.

You will manage study timelines, resource needs, and collaborate with Biostatistics to implement data standards, develop ADaM datasets, and ensure compliance with CDISC and regulatory guidelines across trials.

Qualifications

• Bachelor’s degree required.
• 5+ years relevant work experience within an organization with a focus on data management and analysis.
• 5+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO.
• 5+ years relevant industry experience.
• 5+ years clinical trial experience.
• 3+ 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.
• Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages).

Responsibilities

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
• Authors CDISC ADaM analysis data set specifications including the identification of potential data issues or areas of critical data examination.
• Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
• Manages the end-to-end programming of deliverables from CRF (Case Report Form) collections through electronic submission including preparation of electronic submissions components; works with SMEs to ensure compliance to submission standards.
• Serves as the Statistical Programming Lead to achieve milestones for a study; collaborates with PL and/or manager on issues or resource needs.
• Verifies program consistency and usage of data, analysis and submission standards within a study 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.

Skills

SAS Base

SAS MACRO

SAS STAT/GRAPH

Clinical trials

CDISC ADaM

UNIX familiarity

R (genomics tools)

Data standards

Education

Bachelor's degree

Job description

Biogen operates a hybrid role in the Cambridge/Durham area seeking a Senior Analyst, Statistical Programming to lead programming activities and oversee vendor work, delivering submission-ready outputs with minimal supervision.

You will manage study timelines, resource needs, and collaborate with Biostatistics to implement data standards, develop ADaM datasets, and ensure compliance with CDISC and regulatory guidelines across trials.