The Principal Statistical Programmer will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and ADaM specifications, as well Tables, Listings, and Figures ("TLFs") for analysis of efficacy data. He/she will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. He/she will serve as a Programming Lead and represent Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams. The Principal Statistical Programmer will act as a mentor to all other Statistical Programmers. He/she must demonstrate, at a minimum, an expert ability to comprehensively integrate statistical concepts with SAS Programming in the most efficient and effective manner.
* Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
* Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
* Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs based on Protocol SAP.
* Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.
* Supervise/manage external vendors and contract programmers.
* Oversee progress of programming activities.
* Review, maintain, and approve protocol specific documents as necessary.
* Provide guidance and mentoring to peer and junior-level Programmers.
* Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
* Contribute ideas and thoughts towards the optimization of standard operating procedures.
* Lead team meetings when appropriate.
* Any other activities as required.
* Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
* Proven ability to:
* Develp and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
* Independently and cllaboratively resolve problems
* Clearly cmmunicate processes and standards with management and team members
* Expertise in using SAS/Base, SAS/Macro, SAS/STAT.
* Knowledge of SAS/Graph, and SAS/SQL
* Knowledge of:
* SDTM and ADaM
* Relational Databases.
* Good Clinical Practices.
* Good Programming Practices.
* 21CFR Part 11 Standards.
* Integrated Summary Safety/Efficacy Analyses.
* Safety data and Coding Dictionaries (MedDRA and WHODD).
* ICH eCTD frmat.
* Bachelor's Degree (Minimum) or Master's Degree (Preferred) in Biostatistics, Statistics or another related discipline
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
About Alexion Pharmaceuticals
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare diseases.