Senior Manager, Statistical Programming

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.

Summary:

Roles and Responsibilities:

• Act as an independent therapeutic area trial Programmer for assigned trials, take a programming leadership role on the Biometrics project team.
• Maintain efficient interfaces with internal and external customers Trial Data Manager and the Trial Statistician for high level strategic advice.
• Manage complex trials and aid in 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.
• Participate and support SOP, process, and work aid development.
• Oversee programming style, quality of Biometrics contributions and compliance with timelines.
• To program as required and oversee delivery, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for ISS and ISE with high quality and within milestones.
• Ensure that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures.
• Induct, supervise, and train programmers on programming skills, trial and project level activities, and internal processes.
• Support quality control and quality audit of deliverables.
• Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.
• Follow outsourcing strategy as defined within Biometrics and supervise all outsourced activities outsourced to CRO.
• Provide input on process improvement initiatives and participate in non-clinical project activities with support from management.
• Operationally manage Statistical programmers as needed.

Education & Experience:

• BS/BA, MS Preferable
• 8-10 years in senior programming /statistical role within pharmaceutical industry strongly preferred

Knowledge, Skills & Abilities:

• Strong hands-on SAS programing skills for clinical trial reporting.
• Excellent SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
• Strong CDISC SDTM and ADaM experience.
• Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials.
• Strong interpersonal, organizational, and multi-tasking skills. Excellent attention to detail and problem-solving skills.
• Good trial management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude.
• Good written and oral presentation skills and ability to communicate effectively.
• Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment.
• 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.

Travel Requirements:

Education:

Pay Information:

Work Arrangement:

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 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.comor follow us on LinkedIn andX.

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.