Biogen
Sr. Principal Analyst, Statistical Programming
Remote, USA · Principal
Sponsorship not specified$134k-$179kDetected 1 day ago
AlgorithmsLinuxStatisticsClinical TrialsFDA RegulatorySAS
About the role
- The Senior Principal Analyst, Statistical Programming reporting to Statistical Programming Manager, West Coast Hub, Biogen.
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
- Serves as the Statistical Programming Lead to achieve milestones for a drug program which may include individual study or integrated studies
- evaluates task objectives, collaborates with PL and/or manager on issues or resource needs
- 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)
- Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT
- You love analytics and are passionate about using data to drive key business decisions.
Requirements
- 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
- 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
Nice to have
- Bachelor's degree required, Masters or PhD in Statistics or Mathematics preferred
- Preferred Skills
- Experience with ISS/ISE and NDA/BLA submission is a plus
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid Maternity and Parental Leave benefit
- You love learning new technological skills and working through collaboration.
- 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)
- Employee stock purchase plan
- 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.
Company info
- He/She will lead and oversee statistical programming activities of internally and externally through vendors at study level or project level, ensure all statistical programming deliverables in adherence to company SOPs and ICH/GCP.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- We are a global team with a commitment to excellence, and a pioneering spirit.
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.