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Bristol-Myers Squibb

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4.2

based on 116 Reviews

51 Bristol-Myers Squibb Jobs

Manager, Statistical Programming

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

4.2

based on 116 Reviews

3-8 years

Hyderabad / Secunderabad

1 vacancy

Manager, Statistical Programming

Bristol-Myers Squibb

posted 1d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy NDA Clinical Data Management Life Sciences Statistical Programming MS Office

+ 3 more

Job Description

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Position Summary

Managers of Statistical programming provide programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for analyzing and reporting clinical data. Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.

Key Responsibilities

Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs

Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis

Support the electronic submission preparation and review

Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities

Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers

Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices

Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors

Support improvement initiatives

Minimum Requirements:

Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required.

At least 3 years programming experience in industry recommended.

For US positions: US military experience will be considered towards industry experience.

Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.

Understanding of clinical data structure (e.g. CDISC standards) and relational database.

Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.

Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.

Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.

Have good understanding of regulatory, industry, and technology standards and requirements.

Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.

Demonstrated ability to work in a team environment with clinical team members.

Preferred Requirments:

Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)

Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements

Experience in other software packages (e.g. R)

Experience with the Linux operating system

Employment Type: Full Time, Permanent

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What people at Bristol-Myers Squibb are saying

3.1

Rating based on 4 Manager reviews

Anonymous · Pharmaceutical & Biotechnology in Hyderabad

Likes

Compensation and benefits are quite good. The health related benefits are better than other employers.

Dislikes

There is no growth and learning as there is no career ladder. Employees in US treats Indians as slave and assign work that is of no visibility to us. They take credit of our work and show it on global portal. For future growth discussions managers comment on the current compensation and says we are paying you better so do what is ass..Read More

Read 4 reviews