Director / Senior Director, Statistical Programming (Medical Affairs) Job at EPM Scientific, Philadelphia, PA

Y2xhTHVvRHU1THBvNGNQSnB6K0UxR05xc1E9PQ==
  • EPM Scientific
  • Philadelphia, PA

Job Description

Title: Director / Senior Director, Statistical Programming (Medical Affairs)

Job Summary: The Director / Senior Director of Statistical Programming will lead and execute all Medical Affairs programming activities. This is a unique opportunity for a hands-on leader to shape and deliver programming strategy and execution in support of real-world evidence (RWE), health economics and outcomes research (HEOR), and post-marketing studies. As the sole statistical programmer on the Medical Affairs team, you will be responsible for both strategic oversight and day-to-day programming execution

Key Responsibilities

  • Lead the Medical Affairs programming activities
  • Oversee the development of analysis data-sets (e.g., ADaM), tables, listings, and figures (TLFs) for RWE, HEOR, and post-marketing studies.
  • Ensure programming deliverables meet regulatory, publication, and internal quality standards.
  • Collaborate cross-functionally across Biostatistics, Statistical Programming, and Medical Writing.
  • Drive innovation in programming practices, including automation, use of R and open-source tools, and integration of real-world data sources.
  • Ensure compliance with CDISC standards, ICH guidelines, and company SOPs.

Qualifications

  • Masters in Statistics (Preferred)
  • 6+ years of experience in statistical programming within the pharmaceutical or biotechnology industry
  • Hands-on experience in designing and analyzing clinical trial data, with proficiency in SDTM and ADaM datasets and statistical software such as SAS and R.
  • Deep understanding of CDISC standards (SDTM, ADaM), regulatory requirements, and publication practices.
  • Strong project management, interpersonal and communication skills.

Location:

  • 3 days a week on-site in the Greater Philadelphia Area.

Job Tags

3 days per week,

Similar Jobs

Colorado Permanente Medical Group

Physician Palliative Care Opportunity with Colorado Permanente Medical Group Job at Colorado Permanente Medical Group

 ...Physician Palliative Care Colorado Permanente Medical Group is seeking a board certified/board eligible Palliative Care physician to support our Denver market. Our Mission Colorado Permanente Medical Group (CPMG) has an exclusive, integrated partnership with Kaiser... 

AMP Solutions LLC

Cleaning Validation engineer Job at AMP Solutions LLC

Job Title: Cleaning Validation Engineer Company: AMP Solutions LLC Location: Onsite New York, NY Job Type: Contract About AMP Solutions LLC: AMP Solutions LLC is a trusted partner in delivering high-quality engineering, scientific, and compliance solutions... 

AdaptHealth LLC

RT Vent - Field-LPN, RN-$5,000 Sign-on Bonus Job at AdaptHealth LLC

 ...nature. The RT will utilize all the resources available within the agency and community to accomplish care objectives. This position will...  ...of clinical experience as a Health Care RT, HME RT or clinical nursing with Vent experience. Valid and unrestricted driver's... 

Proclinical Staffing

Sub Investigator Job at Proclinical Staffing

 ...Sub Investigator - Contract - San Antonio, TX Are you looking to drive groundbreaking medical research and make a real impact-join our client and lead the way in advancing clinical trials! Proclinical is seeking a Sub Investigator to join our client's team in San... 

Broward Children's Center

Teaching Assistant Job at Broward Children's Center

 ...passionate about impactful work and a supportive team environment, BCC may be the perfect place for your career. Summary Assists teacher in all aspects of the educational programs. Education and/or Experience High school diploma or general education degree...