Programming Project Lead - Vaccines

About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives.

Ready? As a Programming Project Lead – Vaccines within our Hyderabad Hub, you’ll be part of a performing team, delivering biostatistics and programming activities throughout the Vaccines R&D value chain (Pre-Clinical, Clinical, Translational, CMC) with our Vaccines Global Biostatistical Sciences team. Programming Project lead – Vaccines provides technical and operational leadership for one or more scientific programming project team(s) and is accountable for all programming activities from study start to regulatory submission and post marketing support at the project level.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

Apply advanced technical experience as a Scientific Programming leader at vaccine project level:

·     Provide leadership, guidance, and hands-on support to ensure high quality and timely scientific programming deliverables within a project. Ensures technical validity, supervises quality control (QC) methods, and ensures compliance to internal standards and SOPs and regulatory requirements

·     Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses.

·     Takes accountability for and provides technical guidance for metadata specifications and project-/study-specific data requirements.

·     Lead regulatory submission activities, including electronic submission packages.

·     Accountable for ensuring the clinical data CDISC packages are delivered and comply with Health Authorities’ (eg: FDA, PMDA, CDE, KFDA,..) expectations.

Act in a project management capacity to ensure scientific programming activities are conducted and completed within the set scope, schedule, and budget:

·     Plan and track programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas.

·     Collaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevant.

Act as Scientific Programming Leader both within GBS department and cross-functionally:

• Lead and/or participate in departmental working groups.

• Contribute to operational process optimization and provide inputs to programming standards.

• Participate in cross-functional working groups.

• Provide guidance to junior staff on programming techniques, project management, and implementation of standards.

• Lead oversight activities for outsourcing engagements; guide team members to effectively interact with external resources.

About you

You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:

• Experience:

• • 10+ years experience in statistical programming clinical research with some Vaccines experience (designs, endpoints, statistical methods, …)

  • SAS: advance technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming

  • Proven success performing, coordinating and overseeing the preparation, execution, reporting, and documentation of all study-level programming deliverables and ability to do the same at project level

  • Demonstrated leadership mindset that includes embracing change, innovating, continuously improving programming practices, motivation, and teamwork in a global team

  • Ability to represent scientific programming effectively through internal and external audits, regulatory interactions, submissions and marketing authorizations

• Skills:

• • • Good understanding of processes associated with clinical trials

    • Ability to independently create specifications

    • Knowledge of descriptive statistics

    • Demonstrate interpersonal skills necessary for effective teamwork

    • Demonstrate ability to organize multiple work assignments and establish priorities

    • Demonstrate critical thinking skills beyond simply following directions or specifications

    • Ability to lead complex and large tasks, demonstration of strong project management skills

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• Education:

• • Bachelors or Masters degree in Statistics, Mathematics, Computer Science or related health sciences or equivalent experience

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• Languages:

• • English: Highly effective communication, both oral and written