Director, Statistical Programming

Position Summary:

The Director, Statistical Programming will be responsible for leading and directing the statistical programming team and strategy for clinical projects across one or multiple therapeutic areas. Ensure delivery of high-quality programming deliverables in project timelines. Statistical Reporting representative on major Apellis initiatives.

Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

•  Operational and functional leadership of one or multiple therapeutic areas (TA).
• Lead and implement the statistical programming strategy in the responsible therapeutic area/s.
• Recruit, develop, mentor, coach people managers responsible for managing individual drug projects. Appraise the performance of direct and indirect reporting associates. Ensure high quality performance management and associates’ career development within his/her TAs.
• Establishes high expectations and goals to ensure organizational success. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
• Manage quality, timeliness, efficiency, and implementation of standards within his/her Unit. Ensure implementation of state-of-the-art programming practices and quality guidelines in compliance with regulatory requirements and Apellis quality standards, to ensure programming deliverables of high quality, on time, and within budget.
• Build and maintain strong partnerships within Apellis Statistical Programming groups and across functions within Biometrics, Regulatory and all development functions.
• Attend Biometrics leadership meeting and extended leadership meeting to represent programming function on strategic and operational level.
• Lead all external and internal resource management activities across programming TAs, as well as contribute to the overall resource planning for programming.
• Manage and builds relationships with external partners and service organizations. Engages in effective management of vendors including development, maintenance and monitoring of effective KPIs and KQIs.
• Anticipates potential problems within and across TAs and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels.
• Lead independently improvement initiatives and/or non-clinical projects for programming and Biometrics.
• Ensure that relevant SOPs/BGs/Working practices are in place and followed.
• Review the planned contents of tables / listings / figures for SCS/SCE and project level documents to ensure efficient production and usefulness of output.
• Lead/participate in external industry/statistical programming activities and forums like PharmaSUG, SUGI, PHuse etc.

Education, Registration & Certification:

• Post-graduate university or college degree in Life Sciences, Statistics, Mathematics, Computer Science, Medical Informatics or equivalent.

Experience:

• 12+ years of experience in global drug development, including at least 8 years in a senior programming/statistical role within the pharmaceutical industry.
• Strong leadership skills including leading people, operations, and innovation globally in complex matrix structures and business models.
• Superior interpersonal skills.
• At least 5 years of people management experience of staff across multiple sites.
• Good knowledge of drug development and commercialization processes.
• Proven ability to proactively identify issues, recommend and implement solutions.
• Strong global project management skills / Track record in successful project management.
• Good knowledge of statistical programming languages like SAS, R and R Shiny

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 15% travel expected. 

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit