Sr. SDTM Programmer

Biogen, Inc.; United States; Remote; USD 90,000 - 117,000; Full time

Benefits offered by this job

Medical, Dental, Vision & Life

Fitness reimbursement

Disability insurance

Paid vacation

Company holidays

Sick time

Parental leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Employee resource groups

Job summary

Biogen is seeking an (Senior) SDTM Programmer to join the SDTM Development and Operations team with presence in the United States and Europe. You will lead study-level SDTM programming activities, collaborate with Analytics, Data Science, and Biometrics to ensure timely, high-quality deliverables, and oversee SDTM work across studies.

The role emphasizes data standards expertise, SDTM end-to-end data flows, and potential Senior level consideration, with a base salary range and bonus

Qualifications

• Bachelor’s degree required.
• 2+ years relevant work experience with a focus on SDTM and statistical programming. (4+ years’ experience for Senior SDTM Programmer consideration.)
• 2+ years proven data standards experience with a focus on SDTM and end to end data flow. (3+ years’ experience for Senior SDTM Programmer consideration.)
• 2+ years of Pharmaceutical/biotechnology/CRO industry experience required.
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape.
• Working cross functionally with Biometrics stakeholders.

Responsibilities

• Lead study level SDTM programming activities and deliverables (annotated CRF, specifications, datasets, define.xml, Study Data Reviewers Guide, etc.).
• Collaborating cross-functionally within Analytics and Data Science, you will work with other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study.
• Represent SDTM Development and Operations in Biogen Portfolio Disease Unit discussions.
• Ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Skills

SAS programming

Lead experience

Clinical data understanding

Cross-functional collaboration

Education

Bachelor’s degree

Tools

SAS

Job description

About This Role

The (Senior) Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the Unites States and Europe.

What You’ll Do

You will lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.). Collaborating cross-functionally within Analytics and Data Science, you will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study. You will represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions. You will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Who You Are

You are a Clinical SAS Programmer with some Lead experience or looking to lead a study. You are someone who is passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data. You are experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space.

Required Skills

• Bachelor’s degree required.
• 2+ years relevant work experience with a focus on SDTM and statistical programming. (4+ years’ experience for Senior SDTM Programmer consideration.)
• 2+ years proven data standards experience with a focus on SDTM and end to end data flow. (3+ years’ experience for Senior SDTM Programmer consideration.)
• 2+ years of Pharmaceutical/biotechnology/CRO industry experience required.
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape.
• Working cross functionally with Biometrics stakeholders.

Salary based depends on region.

Job Level: Professional

Additional Information

The base compensation range for this role is: $90,000.00-$117,000.00 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 per calendar year
• Employee Resource Groups participation

Why Biogen?

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. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.