Associate Director, Statistical Programming

2 weeks ago

Mississauga, Canada Alexion Pharmaceuticals,Inc. Full time

Location: Mississauga, Canada

Job reference: R-202220

Date posted: 06/12/2024

**This is what you will do**:
**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.
- Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team.
- Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as vital.
- Build and/or review programming plans, and ensure appropriate prioritisation and prioritization.
- Act as the primary department contact, when vital, 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

**You will need to have**:

- 7+ years statistical programming experience in the CRO or Pharmaceutical Industry.
- 2-5 years people and project management experience
- 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.
- Sophisticated knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a window's environment with a demonstrated proficiency in 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.
- Sophisticated experience with:

- Constructing technical programming specifications.
- Relational Databases.
- Good Clinical Practices.
- Good Programming Practices.
- 21CFR Part 11 Standards.
- Coordinated Summary Safety/Efficacy Analyses.
- Crafting all files vital to support an electronic submission in the eCTD format.

**We would prefer for you to have**:

- BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
- Proficiencies
- Accountability
- Teamwork
- Decision Quality
- Drive for Results
- Perseverance
- Problem Solving
- Informing
- Peer Relationships
- Time Management
- Building Effective Teams
- Managing Through Systems

  • Associate Director Statistical Programming

    1 month ago

    Mississauga, Canada AstraZeneca Full time

    Job Description / Capsule The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They present a delivery/department mindset and management skills to run and oversee one moderate scope and complexity drug project or multiple smaller

  • Associate Director Statistical Programming

    5 days ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Job Description / Capsule:The Associate Director Statistical Programming is responsible for guiding, supervising, and nurturing a group of programmers. They demonstrate a results-oriented approach and leadership abilities to supervise and manage a single drug project of moderate scope and complexity or several smaller ones.

  • Statistical Programming Associate Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    4 days ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Associate Director, Statistical Programming

    5 days ago

    Mississauga, Canada Alexion Pharmaceuticals Full time

    This is what you will do: The Associate Director of Statistical Programming will be primarily responsible for supervising statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely results. He/she must possess extensive experience and proven...

  • Associate Director, Statistical Programming

    5 days ago

    Mississauga, Canada Alexion Pharmaceuticals Full time

    Location: Mississauga, Canada Job reference: R-202220 Date posted: 06/12/2024 This is what you will do: The Associate Director of Statistical Programming will be primarily responsible for supervising statistical programming activities for multiple clinical studies, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality...

  • Director, Statistical Programming

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to...

  • Statistical Programming Associate Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    2 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Statistical Programming Associate Director

    5 days ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Associate Director Statistical Programming

    2 months ago

    Mississauga, Canada AstraZeneca Full time

    **Job Description / Capsule** The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They present a delivery/department mindset and management skills to run and oversee one moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field they...

  • Director, Statistical Programming

    5 days ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to...

  • Director, Statistical Programming

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to...

  • Statistical Programming Associate Director

    4 weeks ago

    Mississauga, ON, Canada AstraZeneca Full time

    Are you an experienced Statistical Programmer with good knowledge of clinical drug development? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM (Cardiovascular Renal Metabolism) Biometrics to impact a wide range...

  • Associate Director Statistical Programming

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Description / Capsule The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They present a delivery/department mindset and management skills to run and oversee one moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field they...