Manager, Statistical Programming

6 months ago

Hyderabad, India Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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 ofBristol 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 Programmingdevelop collaborative relationships and work effectively withinGlobal 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

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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