Analyst, Statistical Programming

Biogen•Research Triangle Park, NC

21h

About The Position

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. This 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, as necessary, to line management. This includes communication and 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.

Requirements

Bachelor’s degree required, Masters 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 AI and ML concepts

Responsibilities

Co-lead (with supervision), coordinates and manages 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 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
Manage under supervision the end-to-end programming of deliverables 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 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; collaborates 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.

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