Associate Director, Statistical Programming

COMPANY BACKGROUND

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).

Job Summary

The Associate Director of Statistical Programming will be a key member of the clinical development team responsible for ensuring the accuracy and timeliness of programming deliverables for clinical studies. The incumbent will lead and manage statistical programming activities for clinical trial reporting, integrated safety/efficacy analysis, and global regulatory submissions. In addition, the incumbent will possess strong technical understanding of programming principles, documentation, SDTM/ADaM structure, and ICH GCP requirements. The main responsibilities of this position include development of analysis and dataset specifications, vendor management, and QC of key deliverables provided by CRO vendors while adhering to planned project timelines. As a key member of the clinical development and cross-functional teams, this position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders.

Job Responsibilities

• Review and lead quality control (QC) of SAS programming deliverables and vendor management of CROs
• Development and manage timelines for statistical programming deliverables and associated documentation.
• Perform ad hoc analyses as requested.
• Represent statistical programming function at internal and external meetings
• Develop overall strategy regarding preparation and standardization of data packages for BLA submission(s)

Qualifications

• Master’s degree or PhD in Statistics, Biostatistics, Mathematics, or other field with significant quantitative and scientific component. Exceptional BS-level candidates with commensurate industry experience may be considered.
• 8 years or more direct biotechnology or pharmaceutical industry experience in statistical programming, including vendor management experience (e.g. CROs)
• Expertise in CDISC (SDTM/ADaM) standards and implementation, regulatory requirements, and ICH GCP.
• Recent experience with BLA/NDA/MAA submission, as well as ISS/ISE development experience, is highly desirable
• Familiarity with hepatology, gastroenterology, or cardiometabolic therapeutic area is desirable

Technical Requirements and Skills

• Proficient in MS Office Suite (Word, Excel and Power Point)
• Expertise in SAS programming (SAS base, macro, etc.), SDTM/ADaM data standards and documentation, and quality control. Fluency in at least one other statistical programming language such as R or Python, is a plus.
• Strong interpersonal and communication skills; proactive approach.
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution with vendors), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Able to work both independently and in a team environment.
• Ability to work collaboratively with CROs and lead oversight of outsourced programming activities.
• Familiarity with modern ML/AI methodology (e.g. deep learning) and applications is a plus
• Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously.
• Ability to travel if needed (<20%)

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas.

  Pay range: $200,000 - $209,000 per annum

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