Principal Statistical Programmer - Clinical Vaccine Research

As a Principal Statistical Programmer 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.

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:

• Plan and execute high quality and timely statistical programming deliverables in the context of a vaccine project

• At study level for various analyses within a study:

• Review and provide feedback on study documents (e.g.: protocol statistical section, Case Report Form, Statistical Analysis Plan (SAP)); create mock TLFs

• Write and provide the programming specifications for the SDTM/ADaM/TLFs to fulfil the study or project objectives

• Deliver compliant CDISC data package with all relevant documentation (ie: aCRF, reviewers guide, define.xml) fulfilling Heath Authorities expectations

At project level for various analyses within an asset:

• Review and provide feedback on integrated analysis plan and create mock TLFs

• Create core integrated clinical database, pooling SDTM/ADaM across several studies for different reporting purposes like ISS/ISE/ISI, DSUR, PBRER or safety surveillance

• Ensure TLF’s format fulfil the requirements of targeted publishing (i.e.: clinical study report, publication, Transparency like Eudract, CTT.gov, lay summaries,...)

• Take leadership, guiding more junior staff and ensuring quality and timely deliveries

• Perform quality control for statistical programming deliverables and complete the associated documentation: Validation plan and quality control (QC) documentation.

• Propose and Program exploratory and/or post’hoc analyses based on problem statement

• Ensure compliance to SOP's, standards, and guidelines.

About you

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

Experience:

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

• SAS (>3 years): excellent technical skills in BASE, STAT, MACRO, GRAPH, SQL, R, and familiar in statistical programming

• Experience programming CDISC SDTM/ADaM datasets and notably vaccines specifics (including writing specifications, P21, proficiency with controlled terminology, value-level metadata, analysis results metadata, define.xml, Reviewers Guide)

• Experience in providing solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying the best solution

• Experience pooling data from multiple studies according to existing specifications

• Experience planning and drafting specifications for pooling data from multiple studies

• Consistent successful experience as a lead on several concurrent studies/projects

• e-submission preparation experience strongly preferred

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

Education:

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