Sr. Manager/ Associate Director of Statistical Programming

Sr. Manager/ Associate Director of Statistical Programming

Dragonfly Therapeutics is seeking a highly motivated and talented Sr. Manager/ Associate Director to lead the statistical programming function. Working together with the Clinical development, Safety, Translational Medicine Teams at Dragonfly, this role will have primary responsibilities for the oversight of CRO programming delivery activities and internally exploratory analyses. Reporting to the Head of biostatistics, this role will provide statistical programming service for the clinical studies at Dragonfly. Overall, the successful candidate will be a key member of Dragonfly’s talented team and play an important role in bringing novel therapies to patients.

Responsibilities:

• Follow outsourcing strategy and supervise all programming activities outsourced to CRO
• Work closely with cross-functional teams to conduct internal exploratory analyses
• Manage complex projects and establish programming strategies
• Develop and comply with project standards and specifications following regulatory guidelines  
• To program as needed and oversee CRO delivery, according to specifications, analysis datasets, listings, tables, and figures for clinical trials with high quality and within milestones
• Ensure that documents and specifications are consistent and comply with standards by providing inputs into protocol design, SAP, CRF, and, data structure

Qualifications:

• 4+ years (Sr. manager)/7+ years (Associate director) statistical programming experience in the CRO or Pharmaceutical Industry
• Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
• Strong CDISC SDTM and ADaM experience
• Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
• Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA
• Thorough understanding of ICH Guidelines and relevant regulatory requirements
• Strong initiative; ability to work with a variety of both internal and external stakeholders
• Excellent attention to detail and problem-solving skills
• Experience overseeing CRO relationships is preferred
• Good written and oral communication skills;
• Ability to work/think creatively and independently