
Experienced I Statistical Programmer
6 days ago
**Job Function**:
Data Analytics & Computational Sciences
**Job Sub**Function**:
Biostatistics
**Job Category**:
Scientific/Technology
**All Job Posting Locations**:
Bangalore, Karnataka, India, IN022 Hyderabad, PENJERLA, Telangana, India
**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.
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