Principal Analyst, Statistical Programming

Biogen•San Francisco, CA

About The Position

About This Role The Principal Analyst, Statistical Programming reporting to Associate Director of Statistical Programming, Biogen West Coast Hub. leads and oversees statistical programming activities of internally and externally through vendors in the 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. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs. What You’ll Do Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight. Authors CDISC ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination. Works with statistics on defining and documenting programming endpoint 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. Serves as the Statistical Programming Lead to achieve milestones for a study; 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. Who You Are You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration.

Requirements

7+ years relevant work experience within an organization with a focus on data management and analysis
7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
7+ years relevant pharmaceutical/biotech industry experience
7+ years clinical trial experience
5+ 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
Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
Management skills, and ability to effectively lead and collaborate across functions
Attention to detail including proven ability to manage some competing priorities

Nice To Haves

Experience with ISS/ISE and NDA/BLA submission
R Programming skill

Responsibilities

Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight.
Authors CDISC ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination.
Works with statistics on defining and documenting programming endpoint 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.
Serves as the Statistical Programming Lead to achieve milestones for a study; 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