Principal Statistical Programmer

3 days ago

Hyderabad Telangana, India Novartis Full time

**Summary**:

- Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines.

**About the Role**:
**Major accountabilities**:

- Lead statistical programming activities for several studies or drive the implementation of data analytics reports -Make decisions and propose strategies at study or project level.
- May act as functional manager for local associates including providing supervision and advice on functional expertise and processes.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), e.g. as representative in study or project-level team.
- Ensure project-level standardization -Provide and implement programming solutions; ensure knowledge sharing.
- Act as expert in problem-solving aspects.
- Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc -Leads/co‐leads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Key performance indicators**:

- Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across functional activities and deliverables.
- Adherence to Novartis policy and guidelines -Customer / partner feedback and satisfaction

**Minimum Requirements**:
**Work Experience**:

- Biostatistics.
- Clinical Research Phases.
- R&D Portfolio Management.
- Statistical Programming.
- Data Management & Systems.
- Regulatory Submissions.
- Innovative & Analytical Technologies.
- Clinical Trial Design, Data Review & Reporting.

**Skills**:

- Classification Systems.
- Clinical Trials.
- Computer Data Storage.
- Computer Programming.
- Cross-Functional Teams.
- Data Analysis.
- Data Structures.
- Initiative.
- Programming Languages.
- Reporting.
- Statistical Analysis.

**Languages**:

- English.

Division

Development

Business Unit

Innovative Medicines

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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