Experienced I Statistical Programmer HyderabadBangaloreMumbai

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

Integrated Data Analytics and Reporting (IDAR)

Experienced I Statistical Programmer (ADAMs Programming)

(*Title may vary based on Region or Country requirements)

Position Summary:

The Experienced Programmer is an individual contributor with knowledge of data structures industry

standards programming languages and programming methods. This role supports data analyses and

reporting activities within trial activities in accordance with departmental processes and procedures.

This position is a member of the programming team capable of supporting programming activities of one

or more trials of low to medium complexity/criticality and may contribute to departmental innovation

and process improvement projects.

Principal Responsibilities:

Completes and may lead programming trial activities of low to medium complexity and/or criticality with high quality and timeliness of deliverables.

Accountable for the design and development of programs in support of clinical research analysis and reporting.

Performs appropriate level of verification of programming and reporting activities. Reviews and provides input for project requirements and documentation.

Supports submission activities including but not limited to creation verification and delivery of CDISC compliant and/or non-standard data packages and reviewers guides.

Follows departmental processes and procedures ensures use of latest standards and deployment of current technologies.

May contribute to departmental innovation and process improvement projects.

Collaborates effectively with team and cross-functional members.

Ensures continued compliance with required company and departmental training time reporting and other business/operational processes as required for position.

Principal Relationships:

This role reports into a people manager position within the Delivery Unit and is accountable to the Portfolio and Study Leads for assigned activities and responsibilities.

Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring Programming Leads Clinical Data Standards Regulatory

Medical Writing Leads and system support organizations.

Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics Clinical Global Medical Safety Project Management Regulatory Strategic

Partnerships Human Resources.

External contacts include but are not limited to external partners CRO management and vendor liaisons industry peers and working groups.

Education and Experience Requirements:

Bachelors degree or higher and/or equivalent in computer science data science/data engineering mathematics public health or another relevant scientific field (or equivalent theoretical/technical

depth).

Experience and Skills Required:

Approx. 4 years of relevant programming experience preferably in Pharmaceutical CRO or Biotech industry or related field or industry.

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

Experience working in a team environment preferred.

Excellent written and verbal communications skills.

Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. May include SAS R Python etc. SAS knowledge is preferred for Clinical

Programming role.

Basic knowledge of processes methods and concepts relevant to programming.

Required Skills:

Preferred Skills: