Director / Senior Director, Statistical Programming Job at EPM Scientific, Philadelphia, PA

Q3Z2QVVVRGJZU0hNRExGMnVoK0xldDg9
  • EPM Scientific
  • Philadelphia, PA

Job Description

Title: Director / Senior Director, Statistical Programming
Location: Greater Philadelphia Area

Job Summary: The Director/ Senior Director of Statistical Programming will lead and oversee all statistical programming functions, ensuring the delivery of high-quality support for clinical trials and regulatory submissions. This role involves strategic planning, resource management, and collaboration with cross-functional teams to achieve team and company-wide goals.

Key Responsibilities:

  • Oversee the planning, execution, and delivery of statistical programming projects, ensuring timelines and quality standards are met.
  • Develop and implement programming standards, guidelines, and best practices. Ensure compliance with regulatory requirements and industry standards.
  • Work closely with biostatisticians, data managers, and other stakeholders to ensure seamless integration of statistical programming activities within clinical trials.
  • Lead the preparation and review of programming deliverable for regulatory submissions, ensuring accuracy and completeness.

Qualifications:

  • Masters in Statistics, Biostatistics, Computer Science, or a related field.
  • Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry
  • Proficiency in SAS, R, and other statistical programming languages.
  • Strong understanding of CDISC standards (SDTM, ADaM).
  • Demonstrated experience in leading a clinical asset through all phases of development
  • Proven expertise in regulatory submissions, including leading and managing submission processes
  • Report onsite 3 days a week

Job Tags

3 days per week,

Similar Jobs

Tata Electronics

Senior Manager Business Operations Job at Tata Electronics

 ...reliability, and driving business growth, join us to help shape the future of electronics manufacturing. Responsibilities: The Sr. Manager, Business Operations will drive critical business functions, including contracts, pricing negotiations, and commercial alignment... 

Professional Management Advisors Associates, Inc. (PMAA, Inc...

Environment, Health and Safety Manager Job at Professional Management Advisors Associates, Inc. (PMAA, Inc...

 ...relevant initiatives Participate in and coordinate emergency responses, including chemical or oil spill mitigation Support site safety initiatives in coordination with station managers QUALIFICATIONS A bachelors degree in engineering is essential, along... 

Royal Business Bank

Loan Assistant Job at Royal Business Bank

 ...loan exceptions. Request insurance certificate from borrower or insurance agent. Prepare verification of deposit / mortgage. Assist the Portfolio Manager/Loan Portfolio Specialist in requesting financial report and other required documents from borrower per loan... 

Ashland Springs Hotel

Join the Ashland Springs Hote Team as a Seasonal Banquet Server! Job at Ashland Springs Hotel

 ...guests. This position involves setting up banquet rooms, serving food and beverages, and attending to the needs of guests throughout...  ...Banquet Server is responsible for maintaining a high standard of service, which directly impacts the reputation of our establishment in the... 

Equitable Advisors

Entry Level Wealth Management Associate Job at Equitable Advisors

 ...fast as you're capable. Our LC Elite Program is an established management track designed to help accelerate your success as a Wealth Management...  ...with branch and company strategy Demonstrates a high level of proficiency in their role as a Financial Professional....