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.
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.
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.
Bachelor’s degree required.
~2+ years relevant work experience with a focus on SDTM and statistical programming. (2+ years proven data standards experience with a focus on SDTM and end to end data flow. (2+ years of Pharmaceutical/biotechnology/CRO industry experience required.
~ Good knowledge of clinical data standards, regulatory submission requirements including current global landscape.
~ 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.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families
physical, financial, emotional,
and
social well-being
; Medical, Dental, Vision, & Life insurances
~ Fitness & Wellness programs including a fitness reimbursement
~ Short- and Long-Term Disability insurance
~ Up to 12 company paid holidays + 3 paid days off for Personal Significance
~Employee stock purchase plan
~ Tuition reimbursement of up to $10,000 per calendar year
~ 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. 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. 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.
Sr. SDTM Programmer in remote at Unknown Company
This position is listed as full time and onsite.