Manager, Statistical Programming at Bristol-Myers Squibb

Warsaw, Masovian Voivodeship, Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 4 years programming experience in industry (US military experience considered towards industry experience for US positions)
Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs
In-depth 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
Good understanding of regulatory, industry, and technology standards and requirements
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 4 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

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
Provide comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
Support the electronic submission preparation and review
Review 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; Assess impact on programming activities
Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers
Provide 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
Identify opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
Independently lead and / or perform programming assignments across multiple projects with minimal supervision
Support improvement initiatives

Skills

Key technologies and capabilities for this role

SASStatistical ProgrammingAnalysis DatasetsTables Listings FiguresProgramming ValidationElectronic SubmissionStatistical Analysis PlanData Presentation PlanGBDS StandardsSOPs

Questions & Answers

Common questions about this position

What are the minimum education and experience requirements for this role?

A Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences is required, along with at least 4 years of programming experience in industry. US military experience counts towards industry experience for US positions.

What specific technical skills are required for the Manager, Statistical Programming position?

Proficiency in SAS to produce derived analysis datasets and TFLs is required, along with in-depth understanding of clinical data structure like CDISC standards and relational databases. Additional skills include using tools like MS Office, XML, Pinnacle 21, and handling upstream data such as SDTM.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or what is the work arrangement?

This information is not specified in the job description.

What does the company culture look like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, and life-changing work that transforms patients' lives and careers, with opportunities to grow alongside high-achieving teams and a focus on balance and flexibility.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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