LexingtonFull TimeEngineering
Remotely
clinical programmingsascdiscsdtmadamcros
Job Description
📋 Description
- Provide strategic leadership for statistical programming in clinical programs, ensuring timelines
- Serve as senior technical expert on CDISC standards (SDTM, ADaM) and data submission strategies
- Partner with Biometrics Lead to define long-term strategy, resource planning, and talent
- Drive global SOPs, tools, and workflows to enhance efficiency and quality.
- Oversee CROs and external vendors to ensure high-quality, timely deliverables.
- Lead, coach, and mentor the team, aligning work with department and company objectives.
🎯 Requirements
- Deep expertise in statistical programming in biotech/pharma settings.
- Proven track record leading programming strategy in clinical development, preferably oncology.
- Expert SAS programming knowledge with CDISC SDTM/ADaM and regulatory submission prep.
- Experience managing CROs and external vendors with governance responsibilities.
- Strong leadership, mentoring, and cross-functional influence.
🎁 Benefits
- 401(k) with 4% company match and immediate vesting.
- Medical, dental, and vision insurance with premiums covered by Company.
- Flexible Spending Accounts for healthcare and dependent care.
- Employee assistance program and paid time off with holidays.
- Company-nominated holidays and annual bonus potential.
- Hybrid working arrangement with 2-3 days onsite per week in Lexington, MA.
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