Alexion Pharmaceuticals Associate Director, Statistical Programming in New Haven, United States
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This position can be based from any of the following Alexion locations; Boston, MA, Wilmington, DE or New Haven, CT.
This is what you will do:
The Associate Director of Statistical Programming will be primarily responsible for overseeing statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use his/her strong people management skills and supervisory skills to provide direct line management to the statistical programmers, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices.
You will be responsible for:
Serve as the Lead Programmer and Manager of the statistical programming efforts. This may include additional responsibilities including, but not limited to:
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.
Independently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using Alexion specifications.
Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
Provide secondary reviews of Statistical Programming deliverables.
Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Responsibilities will include, but are not limited to:
Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
Create and/or review programming plans, and ensure appropriate resource allocation and prioritization.
Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards
Assume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.
Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.
Serve as an Administrator of the SAS Software on the Department Servers.
Any other activities as required.
You will need to have:
7+ years statistical programming experience in the CRO or Pharmaceutical Industry.
2-5 years people and project management experience in the CRO or Pharmaceutical Industry.
Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.
Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion.
Strong verbal and written communication skills - ability to clearly and effectively present information.
An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.
Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs.
Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
Advanced experience with:
Constructing technical programming specifications.
Good Clinical Practices.
Good Programming Practices.
21CFR Part 11 Standards.
Integrated Summary Safety/Efficacy Analyses.
Safety data and Coding Dictionaries (MedDRA and WHODD).
Creating all files necessary to support an electronic submission in the eCTD format.
BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers 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.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here (https://careers.astrazeneca.com/) .