Senior SDTM Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee SDTM programming tasks and deliverables at the study level.

• Provide annotated Case Report Forms (aCRF), specifications, datasets, define.xml, and Study Data Reviewers Guides.

• Collaborate across various departments within Analytics and Data Science.

• Partner with study leads in the Biometrics organization to guarantee timely and high-quality SDTM outputs.

• Represent the SDTM Development and Operations team in discussions within the Biogen Portfolio Disease Unit.

• Ensure the delivery of quality SDTM packages to the Statistical Programming group through programming and supervision of study SDTM tasks.

• Investigate and implement analytics initiatives to enhance the transformation of clinical data.

⛳️ Requirements

• A Bachelor’s degree is mandatory.

• A minimum of 2 years of relevant experience focusing on SDTM and statistical programming (4+ years’ experience is required for Senior SDTM Programmer candidates).

• At least 2 years of demonstrated experience with data standards, concentrating on SDTM and the end-to-end data flow (3+ years’ experience is needed for Senior SDTM Programmer candidates).

• A minimum of 2 years of experience in the Pharmaceutical, biotechnology, or CRO industry is required.

• Strong understanding of clinical data standards and regulatory submission requirements, including the current global environment.

• Experience in clinical SAS programming.

• Background in SDTM and statistical programming.

• Proven experience working collaboratively with Biometrics stakeholders.

🏝️ 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 along with additional time off for year-end shutdown (Dec 26-Dec 31).

• Up to 12 company-paid holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Opportunities to participate in Employee Resource Groups.

• Short-term and long-term incentives, including cash bonuses and equity incentive options.