Sr Principal Analyst, Statistical Programming

Biogen•Cambridge, MA

1d•Hybrid

About The Position

The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities, both internally and externally through vendors. This includes 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. The role involves partnering with Biostatistics to deliver high quality, submission-ready statistical outputs. Responsibilities also include providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program milestones, escalating issues, and estimating resource needs. The Senior Principal Analyst leads a drug program team of statistical programmers, ensuring communication and quality oversight of vendors. This individual represents the Statistical Programming perspective to the study team or Clinical Development Team, often as the sole functional representative. The role contributes to implementing the Data and Programming Strategy, provides input to Data Standards personnel and DM on strategic direction, and partners with the PL to ensure appropriate statistical programming standards implementation. They develop and implement standard programming practices across studies or programs and collaborate on tools and process improvement for Statistical Programming. This is a hybrid position requiring in-person workdays at facilities in Cambridge, MA.

Requirements

Bachelor’s degree required.
10 years relevant work experience within an organization with a focus on data management and analysis.
10+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO.
10+ years relevant industry experience.
10+ years clinical trial experience.
5+ years clinical database experience.
CDISC and/or submissions experience.
Extensive knowledge of drug development process and clinical trials.
Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines.

Nice To Haves

Masters or PhD in Statistics or Mathematics.
Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages).
Familiarity AI and ML concepts.

Responsibilities

Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight.
Considered a statistical programming expert within the department.
Authors 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 and/or contributing to TA level algorithms.
Manage the end-to-end programming of deliverables through 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 to ensure compliance to eSUB standards.
Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON.
Serves as the Statistical Programming Lead to achieve milestones for a drug program; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs.
Verifies program consistency and usage of data, analysis and submission standards across the department 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