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 https://apellis.com/careers/benefits/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

 EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.  

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.