About this role:
The Principal Analyst, Statistical Programming is primarily responsible for leading the Management of several study SDTM operating activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc) under an FSP operating model. Collaborating cross-functionally within Biometrics, he/she may serve as a leader or provide support in developing and implementing best practices and processes for optimization of the SDTM delivery model. He/She reviews the study pipeline, and serves as a first line for routine day-to-day activities for FSP resources, and review of metrics related to SDTM quality and timelines. This role will ensure quality SDTM package delivery to the Statistical Programming group through oversight of the model.
He/she leads or participates in cross-functional teams to coordinate ADaM Data standardization efforts across the Quantitative Sciences and Development Organization (QSDO). He/she will be instrumental and directly contribute/develop in building ADaM templates. Acting as an ADaM consultant, he/she supports and educates colleagues and clinical study teams across QSDO. He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on QSDO's behalf.
Principle Responsibilities:
The candidate will work very closely with SDTM Leads and ensure high quality study deliverables are in a timely manner.
Oversight of vendor/FSP resources workload and quality measurement. Serves as first line for in SDTM escalation pathway
ADaM Standards Development and Maintenance
Develop, maintain, and enhance ADaM standards, ensuring alignment with CDISC ADaM Implementation Guide (ADaMIG) versions, evolving regulatory guidance, and company needs.
Create and maintain ADaM dataset specifications, including metadata templates, controlled terminology, and traceability documentation.
Serve as the primary point of contact for ADaM standards-related questions, guidance, and implementation best practices.
Contribute towards Standard TFL Development and Maintenance
Collaborate with statistical programming and biostatistics teams to ensure standard TFLs align with ADaM dataset design and analysis requirements.
Provide guidance on TFL best practices, including automation strategies and standardization approaches.
Participate in Data Standards Governance activities to ensure consistency and quality with study level ADaM implementation.
Training and Knowledge Sharing
Develop and deliver training materials, workshops, and documentation to educate teams on ADaM standards, standard TFLs, and implementation strategies.
Support internal stakeholders with expertise in ADaM dataset design, structure, and programming best practices.
Participate on the CDISC Analysis Data Model Team to ensure continued education and awareness of evolving ADaM standards and that Biogen is part of the active CDISC ADaM community to enable escalation of internal questions to a network of industry ADaM professionals.
Participates in external initiatives to proactively adopt industry trends and anticipate regulatory needs.
Who You Are:
You are person who has directly contributed to the development of SDTM and ADaM within Statistical Programming. You are someone who is passionate about data, data structures, data transformations and standardization of clinical data. You are active in contributing to the CDISC working groups/community.
Qualifications:
Bachelor’s Degree is required.
6+ years relevant work experience with a focus on data statistical programming is required.
Strong knowledge of CDISC standards(SDTM/ADaM), regulatory and drug submission requirements, and current regulatory trends including global landscape is required.
Macro Programming experience is required.
Deep understanding of drug development and biopharmaceutical industry is required.
Strong project management skills, and the ability to effectively lead and collaborate with various business functions is required.
High attention to detail, including proven ability to manage multiple, competing priorities is required.
Excellent oral and written communication as well as effective presentation skills is required.
Demonstrated problem solving and conflict resolution is required.
Programming experience in SAS and/or ‘R’ .
Additional Information
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; including, but not limited to:
- 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 our DE&I efforts.
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.
Top Skills
Biogen Cambridge, Massachusetts, USA Office
225 Binney Street, Cambridge, MA, United States, 02142
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