Senior Director, Statistical Programming (EDG-2025064)

About Edgewise Therapeutics:

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position:

Reporting to the Head of Biometrics, the Senior Director of Statistical Programming will be responsible for statistical programming activities in support of clinical trials, including oversight of vendors and contract programmers to ensure quality deliverables, and to validate results. May also perform exploratory analyses and programming.

Essential Job Duties and Functions:

• Work closely with the Edgewise Therapeutics cross-functional team, including, but not limited to Statistics, Medical, Clinical Operations, and Data Management.
• Comply with applicable national and international laws, regulations, including, but not limited to applicable Good Clinical Practices (GCPs), ICH, 21 CFR Part 11, and Data Privacy Regulations.
• Comply with Edgewise Therapeutics policies, standard operating procedures, and other written instructions.
• Demonstrate effective leadership and working skill in teamwork, delegation, organization and coordination.
• Demonstrate a high level of professionalism and personal integrity when representing the Company.
• Assisting with the selection of Contract Research Organizations (CROs) or other vendors for statistical, programming activities, covering both programming for data standards compliance, as well as tables, listings and figures (TLFs).
• Perform exploratory analyses in support of clinical trials.
• Oversight of all statistical programming activities done by co-development partners, CROs or other vendor(s). This oversight will include but not be limited to:
• Review and validation of technical programming specifications and programs
• Review of SDTM and ADaM datasets
• Quality check of SAP specific tables, listings, and figures
• Filing of all statistical programming related study documentation.
• Ensures programs and processes are developed, implemented, and effectively administered.
• Oversees the investigation and implementation of new procedures and technologies relating to statistical programming.
• Lead SOP development for standardization of statistical programming processes. Ensure that appropriate SOPs and guidelines are available, understood, and followed.
• Input and accountability for development of timelines, project management of all end-to-end statistical programming deliverables in collaboration with cross-functional team members and vendors on assigned studies.
• Develop and execute strategies for working with external vendors, managing contracts and ensuring the right talent and resources are available.
• Ensures that out-sourced statistical programming tasks are performed according to GCP, approved SOPs, and protocol.
• Manages performance and quality issues with vendors and escalates when needed.
• Participates as subject matter expert during regulatory inspections and/or vendor audits as needed.
• Provides input into the budget for any statistical programming software, systems, and/or activities.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:

• Education: BS/BA at minimum with MS preferred and 12+ years of experience in Biotech and/or Pharmaceutical industries, or equivalent;
• Extensive statistical programming and clinical trial knowledge.
• Management roles within Biometrics, with effective people management, interpersonal, communication, and negotiation skills.
• Expert-level experience as SAS programmer.
• Subject-matter expert regarding CDISC-SDTM/ADaM data standard specifications.
• Team player, capable of adapting to changing demands and aggressive timelines.
• Experience working with safety data and coding dictionaries (MedDRA and WHODRL).
• Experience with regulatory submissions and drug development processes.
• Familiarity with XML, and XML validation tools.
• Experience integrating datasets across multiple clinical studies to support an ISS/ISE.
• Interpersonal skills and excellent written/oral communication skills, including grammatical and technical writing skills.
• Ability to self-motivate and lead with confidence is critical.
• Excellent organizational and time management skills, sense of urgency.
• Strong analytical and problem-solving skills.
• Project Management skills.

This is a full-time position (40 hours/week) that has been designated a remote position. Less than 10% travel.

Salary range: $220,000 - $290,000, title and salary commensurate with experience.

Our Benefits:

We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.