Experienced I Statistical Programmer

on:**
Data Analytics & Computational Sciences
Job Sub Function:
Biostatistics
Job Category:
Scientific/Technology
All Job Posting Locations:
IN004 Bangalore, IN020 Mumbai Arena Space, IN022 Hyderabad
Job Description:

Principal Responsibilities:

• Designs and develops statistical programs in support of clinical research analysis and reporting activities.

• Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities.

• Maintains statistical programming documentation as appropriate.

• Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.

• Performs activities in compliance with departmental processes and procedures.

• Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals.

• Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables.

• 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 Relationships:

• Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities

• Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing.

• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical - Primary interfaces within clinical project (trial), program, and submission teams.

• External contacts include but are not limited to external partners including CROs.

Qualifications - External

• Bachelor'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 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field.

• In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred.

• Working knowledge of processes and concepts relevant to Statistical Programming.

• Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

• Demonstrated written and verbal communication skills.

• Experience working in a team environment.