Biogen
Sr Principal Analyst, Statistical Programming
Biogen, Myrtle Point, Oregon, United States, 97458
Why consider this job opportunity
Salary up to $179,000
Opportunity for short‑term and long‑term incentives, including cash bonuses and equity incentives
Comprehensive benefits package including medical, dental, vision, and life insurance
Minimum of 15 days of paid vacation plus paid time off during the year‑end shutdown
Support for professional development through tuition reimbursement of up to $10,000 per year
Collaborative and inclusive work environment focused on individual contributions and team success
What to Expect (Job Responsibilities)
Lead the management of study SDTM operating activities and deliverables under an FSP operating model
Oversee vendor/FSP resources workload and quality measurement, serving as the first line for SDTM escalations
Develop, maintain, and enhance ADaM standards, ensuring alignment with regulatory guidance and company needs
Collaborate with statistical programming and biostatistics teams to ensure standard TFLs align with analysis requirements
Conduct training and knowledge‑sharing sessions on ADaM standards and programming best practices
What is Required (Qualifications)
Bachelor’s Degree is required
Minimum of 8 years of relevant work experience in statistical programming
Strong knowledge of CDISC standards (SDTM/ADaM) and regulatory submission requirements
Programming experience in SAS and/or R is required
Excellent oral and written communication skills, along with strong project management abilities
How to Stand Out (Preferred Qualifications)
Direct experience contributing to the development of SDTM and ADaM within statistical programming
Active participation in CDISC working groups or community
Proven ability to manage multiple competing priorities effectively
Strong problem‑solving and conflict resolution skills
Familiarity with macro programming techniques
Equal Opportunity Disclaimer We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top‑tier employer.
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Salary up to $179,000
Opportunity for short‑term and long‑term incentives, including cash bonuses and equity incentives
Comprehensive benefits package including medical, dental, vision, and life insurance
Minimum of 15 days of paid vacation plus paid time off during the year‑end shutdown
Support for professional development through tuition reimbursement of up to $10,000 per year
Collaborative and inclusive work environment focused on individual contributions and team success
What to Expect (Job Responsibilities)
Lead the management of study SDTM operating activities and deliverables under an FSP operating model
Oversee vendor/FSP resources workload and quality measurement, serving as the first line for SDTM escalations
Develop, maintain, and enhance ADaM standards, ensuring alignment with regulatory guidance and company needs
Collaborate with statistical programming and biostatistics teams to ensure standard TFLs align with analysis requirements
Conduct training and knowledge‑sharing sessions on ADaM standards and programming best practices
What is Required (Qualifications)
Bachelor’s Degree is required
Minimum of 8 years of relevant work experience in statistical programming
Strong knowledge of CDISC standards (SDTM/ADaM) and regulatory submission requirements
Programming experience in SAS and/or R is required
Excellent oral and written communication skills, along with strong project management abilities
How to Stand Out (Preferred Qualifications)
Direct experience contributing to the development of SDTM and ADaM within statistical programming
Active participation in CDISC working groups or community
Proven ability to manage multiple competing priorities effectively
Strong problem‑solving and conflict resolution skills
Familiarity with macro programming techniques
Equal Opportunity Disclaimer We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top‑tier employer.
#J-18808-Ljbffr