Associate Director, Clinical Data Standards

Key Skills

Apache Hadoop, C Programming, C++, Data science techniques, Java Programming, Machine learning techniques, MapReduce, Python Programming, PyTorch, R Programming, Scala Programming, SQL, TensorFlow

Job Description

The Role:

• Located in Cambridge, MA and reporting to the Director, Clinical Data Standards and Integration, the Associate Director Clinical Data Standards will be responsible for leading the initiative to utilize internal and external partners to develop and maintain Moderna Clinical Data Standards Governance; to ensure proper utilization of the clinical data standards and adherence of associated standards processes across clinical development.

Here’s What You’ll Do:

• Responsible for developing and promoting the strategy and infrastructure for the creation, maintenance, and implementation of clinical data standards across all therapeutic areas across Moderna’s portfolio.
• Builds relationships across the Moderna organization and with CRO partners in support of the standards vision and implementation to support data alignment across functional areas and within each therapeutic area.
• Responsible for development and maintenance Moderna’s Clinical Data Standards as well as the procedural documents and charters relating to global data standards
• Leads cross-functional standards initiatives internal or external to Moderna and helps to ensure coherence of standards initiatives across organization. Leads implementation of data standards practices within vendor relationships.
• Leads implementation of Clinical Data Standards utilizing metadata development tools while enhancing connectivity between Clinical Environments
• Identifies and drives data standards related initiatives to enhance efficiencies within the data flow. Evaluates data standards and governance processes and metrics for continuous improvement opportunities.
• Consult with CRO and vendor partners to establish current and forward-looking standardized electronic Case Report Forms (eCRFs) and data checks.
• Develops training strategy and ensures consistent training program for standards for internal stakeholder and external partners
• Conducts periodic review and development of metrics to assess standards utilization and development trends
• Creates and delivers clinical data standards communication, newsletters etc. to support data standards awareness, adoption, utilization and compliance.

Here’s What You’ll Bring to the Table:

• Bachelor’s Degree in computer science or a science-based subject is highly preferred
• At least 8 years of data science, data analysis or clinical data management experience in industry, with experience across indications and EDC platforms
• Deep understanding of drug development and biopharmaceutical Industry required
• Extensive knowledge of standards, regulatory and drug submission requirements and current regulatory trends Including global landscape; including thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
• Strong management skills, and ability to effectively lead and collaborate with various business functions
• Demonstrates leadership, problem solving, conflict resolution, and team building skills
• Demonstrated ability establish effective business relationships with external stakeholders, including implementing process change at a vendor
• Proven ability to manage multiple competing priorities
• Strong technical skills across data platforms
• Experienced with CDISC (CDASH, SDTM, ODM.XML) and other industry standards
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
• Experience with Spotfire or other data visualization software
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Experience in regulatory GCP inspections/audits

Here’s What We’ll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)