Hybrid Senior Statistical Programming Lead

Biogen; Cambridge (MA); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

Holidays + Personal days

Sick time

Maternity and Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking a Senior Analyst, Statistical Programming to lead programming activities and supervise vendor output for submission-ready results. You will collaborate with Biostatistics, define algorithms, and ensure adherence to data standards and study milestones.

You will oversee end-to-end programming from CRF to electronic submission, mentor a study team of programmers, and help implement data strategy while driving process improvements across studies.

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 data issues.
• Manages end-to-end programming from CRF collections through electronic submission components.
• Serves as Statistical Programming Lead to achieve milestones for a study and coordinates with PL or manager on resource needs.
• Verifies program consistency and adherence to data standards within a study.
• Informs internal and external project team members of programming requirements and status.

Skills

5+ years relevant work experience

5+ years SAS Base programming

5+ years SAS STAT, GRAPH, MACRO

5+ years clinical trial experience

Knowledge of drug development process

Knowledge of regulatory guidelines (I​

Education

Bachelor’s degree

Tools

SAS Base

SAS STAT

SAS GRAPH

SAS MACRO

UNIX

R

Imaging software

Genomics software

Job description

Biogen is seeking a Senior Analyst, Statistical Programming to lead programming activities and supervise vendor output for submission-ready results. You will collaborate with Biostatistics, define algorithms, and ensure adherence to data standards and study milestones.

You will oversee end-to-end programming from CRF to electronic submission, mentor a study team of programmers, and help implement data strategy while driving process improvements across studies.