Analyst, Statistical Programming
myGwork - LGBTQ+ Business Community, Milwaukee, WI, United States
About This Role
The Analyst, Statistical Programming supports statistical programming activities (with assistance from project team lead or line management) internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses.
Partners with Biostatistics to deliver high‑quality, submission‑ready statistical outputs with supervision. The Analyst is also responsible for providing input to the data management on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their line manager. Co‑leads a small study team of statistical programmers to accomplish tasks, communicate issues, and perform quality oversight of the vendor. Under supervision, he/she represents the Statistical Programming perspective to the study team and is often the sole functional representative.
The Analyst helps to implement the Data Strategy, provides input on the strategic direction of a study, partners with the Data Standard to ensure appropriate statistical programming standards implementation. Implements standard programming practices while also ensuring that they are employed across a small study. Collaborates with data management and statistics on tools and process improvement for Statistical Programming.
What You’ll Do
Co‑lead (with supervision), coordinate and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
Co‑author basic CDISC ADaM (analysis data model) analysis data set specifications, including identification of potential data issues or areas of critical data examination. Work with statistics on defining and documenting programming endpoint algorithms across a study and drug program.
Manage under supervision the end‑to‑end programming of deliverables from CRF collections through electronic submission, including preparation of electronic submission components (input to reviewer's guides, annotated CRF, define and XPTs); work with SMEs in SSM to ensure compliance to ESUB standards.
Participate in efforts to remedy departmental inefficiencies in conjunction with QPT.
Serve as the Statistical Programming co‑lead to achieve milestones for a study; collaborate with PL and/or manager on issues or resource needs.
Verify 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.
Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
Who You Are
You are an analyst with strong statistical programming skills to support and collaborate across functions. You pay close attention to detail and have the proven ability to manage competing priorities. You believe in and live by Biogen's culture essentials in pioneering, think broadly, drive results, ethical and inclusive.
Required Skills
Bachelor's degree required, Master’s or PhD in Statistics or Mathematics preferred
2+ years relevant work experience within an organization with a focus on data management and analysis
2+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
2+ years relevant industry experience
2+ years clinical trial experience
2+ years clinical database experience
CDISC and/or submissions experience
Some knowledge of drug development process and clinical trials
Some 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)
Some familiarity with AI and ML concepts
Additional Information
Job Level: Professional
The base compensation range for this role is: $81,000.00–$105,000.00. Base salary is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Benefits
Medical, Dental, Vision, & Life insurance
Fitness & Wellness programs including a fitness reimbursement
Short‑ and Long‑Term Disability insurance
Minimum of 15 days of paid vacation and 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
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.
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The Analyst, Statistical Programming supports statistical programming activities (with assistance from project team lead or line management) internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses.
Partners with Biostatistics to deliver high‑quality, submission‑ready statistical outputs with supervision. The Analyst is also responsible for providing input to the data management on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their line manager. Co‑leads a small study team of statistical programmers to accomplish tasks, communicate issues, and perform quality oversight of the vendor. Under supervision, he/she represents the Statistical Programming perspective to the study team and is often the sole functional representative.
The Analyst helps to implement the Data Strategy, provides input on the strategic direction of a study, partners with the Data Standard to ensure appropriate statistical programming standards implementation. Implements standard programming practices while also ensuring that they are employed across a small study. Collaborates with data management and statistics on tools and process improvement for Statistical Programming.
What You’ll Do
Co‑lead (with supervision), coordinate and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
Co‑author basic CDISC ADaM (analysis data model) analysis data set specifications, including identification of potential data issues or areas of critical data examination. Work with statistics on defining and documenting programming endpoint algorithms across a study and drug program.
Manage under supervision the end‑to‑end programming of deliverables from CRF collections through electronic submission, including preparation of electronic submission components (input to reviewer's guides, annotated CRF, define and XPTs); work with SMEs in SSM to ensure compliance to ESUB standards.
Participate in efforts to remedy departmental inefficiencies in conjunction with QPT.
Serve as the Statistical Programming co‑lead to achieve milestones for a study; collaborate with PL and/or manager on issues or resource needs.
Verify 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.
Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
Who You Are
You are an analyst with strong statistical programming skills to support and collaborate across functions. You pay close attention to detail and have the proven ability to manage competing priorities. You believe in and live by Biogen's culture essentials in pioneering, think broadly, drive results, ethical and inclusive.
Required Skills
Bachelor's degree required, Master’s or PhD in Statistics or Mathematics preferred
2+ years relevant work experience within an organization with a focus on data management and analysis
2+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
2+ years relevant industry experience
2+ years clinical trial experience
2+ years clinical database experience
CDISC and/or submissions experience
Some knowledge of drug development process and clinical trials
Some 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)
Some familiarity with AI and ML concepts
Additional Information
Job Level: Professional
The base compensation range for this role is: $81,000.00–$105,000.00. Base salary is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Benefits
Medical, Dental, Vision, & Life insurance
Fitness & Wellness programs including a fitness reimbursement
Short‑ and Long‑Term Disability insurance
Minimum of 15 days of paid vacation and 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
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.
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