Manager, Statistical Programming

3 weeks 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 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 Requirements:
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
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