Senior Director, Statistical Programming

The Senior Director Statistical Programming will be responsible for shaping the vision, direction, and strategic framework of the statistical programming function within Biometrics. Manages the statistical programming group, oversees, and manages all activities, both internally and externally by CROs across clinical programs, and ensures standardization across therapeutic areas. The incumbent develops an overall strategy for the programming group and coordinates the effort across therapeutic areas to identify, develop and implement departmental standards, applications, processes, and training. The incumbent is responsible for addressing all administrative functions required for project management such as compilation of resource requirements and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level, and working with the other function heads to develop resource strategies. The incumbent provides timely support to the project teams on all statistical programming matters according to the project strategies.

Primary Responsibilities:

• Demonstrate company values and act as a role model through respect of others, performing collaboratively within and across departments and teams, taking ownership of assignments and striving to deliver quality products in expected timelines.

• Define roles and responsibilities of the statistical programming function with input from within biometrics and across clinical teams.

• Recruit, retain, develop, and mentor team members.

• Establish a scalable statistical computing environment at Keros with biometrics, IT and quality teams.

• Establish strong partnership with biostatistics and statistical programming vendors.

• Establish the standardization of Keros data models across therapeutic areas.

• Establish and coordinate the implementation of standard tools and technology to facilitate analysis dataset creation and analysis results following the Keros standard data models.

• Develop and improve SOPs, WIs and processes.

• Oversee all end-to-end statistical programming activities outsourced to contract resource organizations.

• Ability to perform hands-on execution of all statistical programming activities from SDTM, ADaM, TFLs through regulatory submission and approval as needed.

• Ability to function as lead of compound/study level statistical programming as needed.

• Ability to understand ad hoc requests from cross functional team and produce accurate results quickly as needed.

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 statistical programming considerations and to ensure appropriate interpretation of team needs.

• Able to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.

• Ability to promote collaboration and enhance a culture of trust and respect.

Qualifications

• MS or PhD in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline

• 15+ years of programming experience in statistical programming in the biotechnology and pharmaceutical industry

• 5+ years people management experience

• Experience in developing department strategies and develop department goals and objectives.

• Experience in qualifying and managing vendors.

• Proficiency in SAS programming, knowledge of relevant ICH Guidelines. Proficiency in in R a plus.

• Thorough understanding of relational databases and their correlation to submission ready database structure. Thorough knowledge of CDSIC data structure requirements

• Thorough knowledge of regulatory requirements concerning electronic submission standards.

• Thorough understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.

• Ability to mentor programming staff in the areas of project management, resource allocation and communication.

• Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.