Statistical Scientist (Kochi)

Job Overview With oversight at a team/site/staff level, lead complex studies and submissions. Develop protocols, review case report forms (CRFs), and develop analysis plans. Provide input or write specifications for tables and analysis files. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Essential Functions - Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Oversees team with same expectations. Prioritizes and works proactively to gain efficiency. - Leadership: Perform as lead statistician on complex studies and for integrated summaries or eSubmissions, where applicable. Through this, works with the team to ensure high quality deliverables, delivers on time within budget, ensures compliance with Standard Operating Procedures (SOPs), ensure consistency across teams and across protocols, manages/delegates data quality issue resolutions. As a lead of groups of studies within a compound, also prioritizes and leads proactively to gain efficiencies in work across protocols. Responsible for driving statistical discussions, actively participates in internal project team meetings, provides timely progress updates. If in lead role, runs meetings, provides timeline updates, assess resource needs, and documents and follows up on actions. Supports colleagues and provides motivation. - Datasets: Writes and maintains programming specifications, with a focus on efficacy. Manages dataset derivations and assignment. May program analysis datasets, including complex domains and derivations. Handles analysis set derivations and assignment. - Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Checks outputs for format and content. Ensures consistency across items produced. May progr .