Principal Programmer ( Data Oversight & Standards)

Principal Programmer - Clinical Data Oversight & Standards provides leadership and oversight for clinical data build programming and vendor deliverables across in-house hybrid and outsourced studies ensuring alignment with CSL standards regulatory requirements and industry best practices.

The role drives governance review and validation processes; leads the implementation of CDASH and SDTM standards; and oversees scalable validation frameworks and data quality controls. Additionally it ensures effective integration of internal and external data into platforms such as the CSL Clinical Data Warehouse while advancing automation AI-driven solutions and strong cross-functional collaboration with Biostatistics Data Management Standards and external partners

Main Responsibilities and Accountabilities:

• Leads and develops a team of Clinical Data Validation Programmers providing direction on clinical data standards validation and oversight activities across in-house hybrid and vendor-supported studies.
• Establishes and drives clinical data governance frameworks including review and validation processes for eCRF builds SDTM datasets specifications and vendor deliverables ensuring compliance with internal standards regulatory requirements and industry best practices.
• Oversees the development implementation and continuous improvement of clinical data standards (e.g. CDASH SDTM) and associated validation check libraries to enable consistent scalable and high-quality data across studies.
• Provides strategic oversight of data integration processes including external data flows and system interfaces ensuring accurate efficient and compliant data ingestion into downstream platforms such as the Clinical Data Warehouse.
• Ensures submission readiness of clinical data by establishing robust quality control frameworks and validation processes aligned with regulatory expectations (e.g. SDTM ADaM ).
• Develops maintains and governs departmental and cross-functional SOPs standards and QMS documentation related to clinical data oversight standards and programming.
• Drives cross-functional alignment by partnering with Biostatistics Data Management Standards and external partners to ensure consistent understanding and application of clinical data standards and quality expectations; provides guidance knowledge sharing and targeted training to support effective implementation across studies.
• Provides oversight and guidance on data storage archival and retrieval strategies to support regulatory submissions pooled analyses and reuse of legacy data in collaboration with Biostatistics and other stakeholders.
• Oversees programming and validation support to ensure availability of high-quality analysis-ready datasets while promoting automation efficiency and innovation through the use of SAS and emerging technologies (e.g. Python AI-driven solutions).

Job Qualifications and Experience Requirements:
Education

• Degree (BSc/MSc/Diploma) in Computer Science Mathematics/Statistics or related area with relevant experience.
• Other degrees and certifications considered if commensurate with related data management/statistical programming experience

Experience

• At least 7 years of relevant experience (either clinical programming and/or statistical programming within the CRO/pharmaceutical environment).
• Significant experience with demonstrated leadership or oversight responsibilities and a strong understanding of the end-to-end clinical data lifecycle including data collection validation standards implementation and regulatory submission requirements.
• Proven expertise in CDISC standards (CDASH SDTM ADaM) and their practical application across studies including review and oversight of datasets specifications and mappings.
• Experience with EDC and/or Clinical Data Warehouse platforms (e.g. Medidata Rave Veeva Vault) with a solid understanding of data flows integrations and database structures.
• Proficiency in SAS programming with working knowledge of Python R or similar languages preferred to support automation and advanced data review.
• Demonstrated experience in establishing or applying data quality frameworks validation processes and governance models in a clinical data environment.
• Proven ability to manage priorities timelines and team deliverables in a fast-paced environment while driving continuous improvement and operational excellence.
• Experience with CROs (either managing a CRO or having worked in a CRO)

Competencies

• Excellent communication and analytical skills.
• Strong interpersonal and effective leadership skills.
• Excellent organizational skills and ability to prioritize individual and team workloads.
• Strong ability to lead and collaborate across cross-functional global teams including oversight of vendor deliverables and alignment with internal stakeholders such as Biostatistics Data Management and Standards.
• Is able to identify and engage internal and external expertise as needed.
• Proven networking skills and ability to share knowledge and experience amongst colleagues.
• Strong written and verbal English communication skills

Work Environment: On-Site Hybrid Requires a minimum of 3 days a week in office work location

The expected base salary range for this position at hiring is $170000 - $201000 USD. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for Waltham MA USA at the time of this posting. Individual base salary for a successful candidate is determined by qualifications skill level experience competencies and other relevant addition to base salary total compensation for this role may also include incentive compensation and equity.

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About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

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