Senior Analyst, Statistical Programming

Biogen•Research Triangle Park, NC

2d•$93,000 - $121,000

About The Position

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/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 (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.

Requirements

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)

Nice To Haves

Masters or PhD in Statistics or Mathematics preferred

Responsibilities

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/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 (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.

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