Principal Analyst, Statistical Programming

Get AI-powered advice on this job and more exclusive features.

The Principal Analyst, Statistical Programming reporting to Associate Director of Statistical Programming, Biogen West Coast Hub, leads and oversees statistical programming activities 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. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs.

• 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.

You love analytics and are passionate about using data to drive key business decisions. You love learning new technological skills and working through collaboration.

• 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

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

Job Level: Management

The base compensation range for this role is: $-$
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

• 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…