Senior Manager, Statistical Programming

Apellis Pharmaceuticals

2d • $181,000 - $271,000

About The Position

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: Independent Project Programmer for major therapeutic area, and/or Project/Technical leader on non-clinical project requiring supervision and coordination of personnel. Ability to offer consulting, training and support to users on applications developed by internal systems group. Independent Statistical Reporting representative on major Apellis initiatives. Roles and Responsibilities: Essential Duties: Independent Therapeutic area lead Coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via external staff oversight. Maintain efficient interfaces with internal and external customers Program Data Manager and the Program Statistician for high level strategic advice. Manage complex projects and establish therapeutic area programming strategies. Develop and comply with project / study standards and specifications following internal and regulatory guidelines and Apellis SOPs and values Develop resource plans as required to support headcount justifications, resource forecasting and allocations Lead programming efforts across the Hematology therapeutic area Responsible for all programming deliverables for the indication/therapeutic area across multiple studies. Supervises multiple Sr. Statistical Programmers Follow outsourcing strategy as defined within Development Operations and supervise all outsourced activities outsourced to CRO. 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. Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science 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 C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. 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 LinkedIn and X.

Requirements

• BS/BA, MS Preferable
• 8-10 years in senior programming /statistical role within pharmaceutical industry strongly preferred
• SAS, CDISC, TLFs, Management, Oversight, Submission, ICH, ISS/ISE
• Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
• Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• NDA/BLA or other regulatory filing experience, including ISS or ISE experience.
• Thorough understanding of ICH Guidelines and relevant regulatory requirements.
• Strong initiative; ability to work with a variety of both internal and external stakeholders
• Experience overseeing CRO relationships
• Excellent attention to detail and problem-solving skills.
• Good written and oral communication skills; Ability to work/think creatively and independently

Responsibilities

• Independent Therapeutic area lead
• Coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via external staff oversight.
• Maintain efficient interfaces with internal and external customers Program Data Manager and the Program Statistician for high level strategic advice.
• Manage complex projects and establish therapeutic area programming strategies.
• Develop and comply with project / study standards and specifications following internal and regulatory guidelines and Apellis SOPs and values
• Develop resource plans as required to support headcount justifications, resource forecasting and allocations
• Lead programming efforts across the Hematology therapeutic area
• Responsible for all programming deliverables for the indication/therapeutic area across multiple studies.
• Supervises multiple Sr. Statistical Programmers
• Follow outsourcing strategy as defined within Development Operations and supervise all outsourced activities outsourced to CRO.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level