Job Summary:

Provide statistical and clinical programming expertise cross-functionally with the clinical study team. This individual will be responsible for the oversight and execution of statistical and clinical programming activities in Keros's clinical development programs. This position will report to the head of Biometrics.

Primary Responsibilities:

• Design/Establish SAS program library for clinical trial reporting, data review tools, and statistical analyses.
• Work with the clinical study team to draft and finalize custom report programming specifications required for data listings, patient profiles, data displays and metrics reporting.
• Develop SAS programs and macros per report programming specifications and perform hands-on SAS programming support as required.
• Support and review clinical data management study documents including Case Report Forms (CRFs), Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, Manual Data Listings Review Plan and Data Transfer Specifications in CDISC format as it relates to the data management functional area.
• Identify and drive opportunities to continuously enhance statistical programming processes, SOPs, and technologies.
• Provides comprehensive programming leadership and strategy across multiple clinical programs and therapeutic areas as needed.
• Lead programming activities in regulatory filings, including the submission of eCTD of BLA/NDA to FDA and other regulatory agencies.
• Oversee the activities of CRO programming team to ensure deliverables are in accordance with service agreements, study milestones/timelines and with quality.
• Oversee/Perform programming activities for SDTM datasets, ADaM datasets, TFLs for CSR, publications, data review, and ad hoc analysis.
• Author/Review data specifications for SDTM and ADaM datasets as well as define.xml files, reviewers guide documents and Pinnacle 21 validation reports.
• Participate in team/vendor meetings and study document reviews, e.g. clinical study protocols, eCRF, data transfer specifications, SAP and mock TFL shells.
• Monitor data integrity throughout study execution by partnering with Biostatistics, Data Management, Clinical Development Operation and Clinical Science.

Qualifications:

• Graduate degree in Biostatistics/Statistics, Computer Science or a related field with 8+ years of statistical programming experience in the pharmaceutical / CRO industry
• 3+ years of overseeing technical professionals in a regulated environment
• Experience building in-house statistical computing environment, SOPs and processes
• Strong hands-on SAS programming skills on both clinical trial reporting and system macro development. General knowledge of R is a plus
• Expert knowledge with CDISC standards for SDTM and ADaM and statistical programming requirements for regulatory submissions
• Recent experience with BLA/NDA or other regulatory filing, including ISS or ISE. Oncology experience is a plus
• Global clinical trial and CRO management experience
• Excellent written and verbal communication skills
• Team player who embraces culture and pace in a startup company

Attributes:

• Ability to evaluate, propose and implement creative approaches
• Ability to work effectively with minimal structure as well as determine when structure is needed and develop related procedures
• Effective communication skills to convey programming considerations
• Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change