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
Provides statistical programming expertise within Biogen, including demonstrated proficiency in CDISC SDTM (Study Data Tabulation Model) and CDISC ADaM (Analysis Dataset model) implementation.
Authors analysis data set specifications including the identification of potential data issues or areas of critical data examination.
Engages with Biostatistics to define and document programming endpoint algorithms
Manage 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
Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT
Serves as the Statistical Programming Lead to achieve milestones for an indication of a drug program/Therapeutic Area; 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
Aligns internal and external project team members on statistical programming requirements, deliverable status, and resource needs

Requirements

BA/BS
12 years relevant work experience within an organization with a focus on data management and analysis
12+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
12+ years relevant industry experience
12+ years clinical trial experience
10+ 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
Familiarity with UNIX
Strong management skills, and ability to effectively lead and collaborate with all functions
High attention to detail including proven ability to manage multiple, competing priorities
Experience with R is a plus

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SAS Base programmingSAS STATSAS GRAPHSAS MACROCDISC SDTMCDISC ADaMdata managementdata analysisclinical database managementprogramming endpoint algorithms

Soft Skills

management skillsleadershipcollaborationattention to detailability to manage multiple priorities