Director - Senior Director, Statistical Programming Job at Bicycle Therapeutics, Lexington, MA

  • Bicycle Therapeutics
  • Lexington, MA

Job Description

Bicycle Therapeutics seeks a Director or Senior Director of Statistical Programming to provide strategic and technical leadership for the statistical programming function supporting clinical development programs. The role involves managing a programming team, overseeing CRO partnerships, ensuring regulatory compliance, and driving operational excellence across all data and analysis deliverables.

Responsibilities

  • Provide strategic leadership and accountability for all statistical programming deliverables and compliance
  • Serve as senior technical expert on CDISC standards, programming methodologies, and data submission strategies
  • Partner with Biometrics Lead to define long-term vision for programming function and resource planning
  • Develop and optimize SOPs, tools, and workflows to enhance efficiency and quality
  • Lead, coach, and mentor programming team while setting clear strategic priorities aligned with organizational goals

Requirements

  • Deep expertise in statistical programming from significant biotech or pharmaceutical experience
  • Proven track record leading programming strategy for clinical development programs, preferably oncology
  • Expert-level SAS programming and CDISC standards (SDTM/ADaM) knowledge
  • Extensive experience preparing data for regulatory submissions (NDA/BLA)
  • Substantial CRO and external vendor management experience with technical oversight
  • Demonstrated leadership ability to mentor programmers and influence cross-functional partners

Compensation: $215,000 - $270,000 base

Job Tags

Similar Jobs

HAN Staff

LPN - Corrections Job at HAN Staff

 ...a dedicated and compassionate healthcare professional who is committed to providing high-quality patient care. New to correctional healthcare? Join a dedicated team delivering high-quality patient care in a safe, secure, and professionally managed correctional... 

Central Office

Substitute Bus Driver Job at Central Office

 ...Job Posting WEST TALLAHATCHIE SCHOOL DISTRICT Post Office Box 129, Webb, MS 38966 (662) 375-9291 (662) 375-9294 (Fax) Qualifications A satisfactory...  ...or be willing to obtain a Class B Commercial Drivers License with a "P" and "S" endorsement. Must be... 

Core-Mark

Warehouse Associate & Forklift Operator Job at Core-Mark

 ...Worker to move and track products in a fast-paced distribution center. You will offload, stock, pick, and replenish items and operate a forklift as part of daily duties.The role requires 6+ months of warehouse experience, ability to work in cooler/freezer and dry areas... 

System One Holdings, LLC

Wind Turbine Blade Repair Technician Job at System One Holdings, LLC

 ...Job Title Wind Turbine Blade Repair Technician Pay Hourly DOE +$140/Day Per Diem Work Location Various locations across the USA 100% Travel Summary The Blade Repair Technician is responsible for wind turbine blades inspections, services or repairs... 

United Flow Technologies

Project Manager III Job at United Flow Technologies

Job Description Job Description At Tesco Controls (a UFT company), our culture is grounded in the idea that the how we achieve results is just as important as the results themselves. Our winning behaviors guide the way we work, collaborate, and growboth as individual...