Statistical Programming Lead - Bengaluru, India - Lifelancer

Description

Integrated Data Analytics and Reporting (IDAR)

Position Title*:
Statistical Programming LeadPosition SummaryThe Statistical Programming Lead is an

experienced Statistical Programmer with advanced knowledge of statistical

programming methods, languages and data structures and capabilities in

leading analysis and reporting activities and programming teams in accordance

to departmental processes and procedures.
This position is accountable for the

planning, oversight and delivery of statistical programming activities

supporting one or more clinical projects, compounds and/or submissions

generally of low-medium complexity/criticality.
The Statistical Programming Lead is

responsible for making decisions and recommendations that impact the

efficiency, timeliness and quality of deliverables and provide leadership,

direction and technical and project specific guidance to programming teams.
As an experienced Statistical Programmer

this position applies advanced technical and problem-solving skills to

complete programming activities of high complexity that may benefit

multiple project teams.
In addition, the Statistical Programming

Lead may contribute advanced knowledge and technical skills to Therapeutic

Area or departmental innovation and process improvement projects.
Principal ResponsibilitiesAs a Programming Lead;Accountable for Statistical Programming

team delivery for one or more clinical projects generally of low to medium

complexity, scope or criticality.
Coordinates and oversees programming team

activities and provides technical and project specific guidance to

programming team members to ensure quality and on-time statistical

programming deliverables in compliance with departmental processes and

procedures.
Develops detailed programming strategy,

specifications and plans the programming deliverables for a one or more

clinical projects. May act as a section lead of programming activities

supporting a clinical program, compound or submission.
Performs comprehensive review of, and

provides input into, project requirements and documentation.
Collaborates effectively with statistical

programming and cross-functional team members and counterparts to achieve

project goals.
As applicable, oversees statistical

programming activities outsourced to third party vendors adopting

appropriate processes and methods to ensure their performance meets the

agreed upon scope, timelines, and quality.
As an experienced Statistical Programmer;Designs and develops programs in support

of complex clinical data analysis and reporting activities.
Applies technical and analytical

expertise to develop and implement solutions for use on clinical projects

leading to increased efficiency and quality.
May contribute to or lead others in an

area of expertise that results in solutions increasing the efficiency and

quality of deliverables across multiple projects.
May play the role of a

Therapeutic/Disease Area Expert contributing to standards strategy and

definition and providing expertise for a specific Therapeutic/Disease area

across value streams.
Ensures continued compliance with

required company and departmental training, time reporting and other

business/operational processes as required for position.
May contribute to departmental innovation

and process improvement projects.
Principal RelationshipsReports into people manager position

within the functional area. Accountable to the Statistical Programming

Portfolio Lead for assigned programming activities and responsibilities.
Functional contacts within IDAR include

but are not limited to, Statistical Programming Portfolio Lead,

Statistical Programmers, peer groups within the function, Data Management,

Regulatory Medical Writing.
Functional contacts within Janssen (as

collaborator or peer) include but are not limited to Clinical Trial Lead,

Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary

interfaces within clinical project (trial), program, and submission teams.
External contacts include but are not

limited to external partners including CROs.
QualificationsBachelor's degree or higher and/or

equivalent in computer science, mathematics, data science/analytics,

public health or other relevant scientific field (or equivalent

theoretical/technical depth). Approximately 6-8 years programming

experience with increasing responsibility, preferably in a

pharmaceutical/clinical trial environment.
Advanced knowledge of relevant

statistical programming languages including SAS (required), other relevant

programming languages (e.g. R, Python etc. preferred), and data

structures.
Demonstrated experience planning and

coordinating programming activities and leading teams.
Demonstrated experience working with

cross functional stakeholder and teams.
Working knowledge of regulatory

guidelines (e.g. ICH-GCP) and relevant clinical RD concepts.
Basic project management skills.
Demonstrated written and verbal

communication skills.