Sr. Analyst, Statistical Programming

Biogen; North Carolina; Hybrid; USD 95,000 - 130,000; Full time

Job summary

Biogen is seeking a Senior Analyst, Statistical Programming for a hybrid role that requires weekly in-person workdays at our offices. The position can be based in Durham, NC or Cambridge, MA.

You will lead statistical programming activities, author CDISC ADaM analysis datasets, and ensure submission-ready outputs while managing vendor collaborations. The role demands 5+ years of SAS programming, UNIX familiarity, and strong clinical trial experience, with a Bachelor's degree.

Qualifications

• Bachelor's degree required.
• 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

• Lead, oversee, and deliver statistical programming activities and deliverables for projects.
• Author CDISC ADaM analysis data set specs and endpoint algorithms.
• Manage end-to-end programming of deliverables from CRF to electronic submission.
• Serve as Statistical Programming Lead to meet study milestones.
• Verify program consistency with data and submission standards.
• Inform team about requirements, status, and resource needs.

Skills

SAS Base programming

SAS STAT

SAS GRAPH

SAS MACRO

CDISC/ADaM

UNIX familiarity

R

Education

Bachelor's degree

Job description

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

About this role

The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs. You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is often the sole functional representative. You will help to implement the Data Strategy, provide input to the Data Strategy Lead and DM lead on the strategic direction of the study to ensure appropriate statistical programming standards implementation and serve as reference for the study to the Data Sharing representative. You will develop and implement standard programming practices while also ensuring that they are employed across a study. You will collaborate with technical programming on tools and process improvement for Statistical Programming .

What you'll do

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
• Authors CDISC (Clinical Data Interchange Standards Consortium) ADaM (analysis data model) 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/ou 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 (Subject Matter Expert) 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.

Who you are

You are a Senior Analyst with strong statistical programming skills who pays close attention to detail and have the proven ability to manage some competing priorities.

Required Skills

• 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).

Job Level

Professional

Additional Information

The base compensation range for this role is: $95,000.00-$130,000.00

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 Pare