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AstraZeneca · 1 month ago

Associate Director, Statistical Programming

US - Boston - MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

7+ years exp

AstraZeneca is a leading pharmaceutical company, and they are seeking an Associate Director of Statistical Programming. The role involves overseeing statistical programming activities for clinical studies, ensuring compliance with standards, and managing a team of statistical programmers.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

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

Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support

Qualification

SASCDISC SDTMADaMStatistical ProgrammingClinical Database DesignRelational DatabasesProject ManagementPeople ManagementClinical PracticesCommunication SkillsProblem Solving

Required

7+ years statistical programming experience in the CRO or Pharmaceutical Industry

4+ years 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

Advanced experience with relational databases

Advanced experience with Good Clinical Practices

Advanced experience with Good Programming Practices

Advanced experience with 21CFR Part 11 Standards

Advanced experience with Integrated Summary Safety/Efficacy Analyses

Advanced experience with creating all files necessary to support an electronic submission in the eCTD format

Preferred

BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)