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Manager, Statistical Programming - Clinical Pharmacology

5+ years
Not Disclosed
10 Feb. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Statistical Programming - Clinical Pharmacology
Location: Hyderabad, TS, IN
Company: Bristol Myers Squibb
Division: Global Drug Development > Global Biometrics & Data Sciences
Job Title: Manager, Statistical Programming (EG100)
Position Summary:
Bristol Myers Squibb is seeking a Manager of Statistical Programming to provide expertise to clinical project teams supporting the development, regulatory approval, and market acceptance of BMS products. The manager will be responsible for the design, development, and implementation of solutions to integrate, analyze, and report clinical data. This role will collaborate with the Global Biometrics & Data Sciences team, external vendors, and cross-functional development teams.

Key Responsibilities:

  • SAS Programming: Create programs to generate analysis datasets and content for tables, listings, and figures.
  • Programming Support: Develop strategies, standards, specifications, and programmed analysis for project teams.
  • Submission Support: Assist with electronic submission preparation and review.
  • Document Review: Ensure alignment of planning documents (e.g., statistical analysis plan, data review plan) with development objectives.
  • Vendor Interaction: Collaborate with vendors on project standards, programming conventions, and file transfers.
  • Quality Assurance: Ensure consistent application of standards and regulatory compliance across deliverables.
  • Efficiency Improvements: Identify opportunities to enhance efficiency and consistency in interactions with vendors.
  • Independent Leadership: Lead or independently perform programming assignments with minimal supervision.
  • Support Initiatives: Participate in improvement initiatives for the team.

Qualifications:

Minimum Requirements:

  • Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences.
  • At least 5 years of programming experience in the pharmaceutical industry, preferably in clinical development.
  • Proficiency in SAS, R, or other programming languages.
  • In-depth understanding of clinical data structures (e.g., CDISC standards, SDTM, ADaM).
  • Strong skills in upstream and downstream data handling and e-submissions.
  • Understanding of regulatory and industry standards, clinical trials, and medical terminology.

Preferred Qualifications:

  • Minimum of 5 years of clinical/statistical programming experience within pharmaceutical development.
  • Knowledge of the drug development process, clinical trial methodology, and regulatory requirements.
  • Familiarity with Linux operating systems and other software packages.

About Bristol Myers Squibb:

Bristol Myers Squibb is a diversified specialty biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients overcome serious diseases. Our mission is transforming patients’ lives through science™.

Company Values: Passion, innovation, urgency, accountability, inclusion, and integrity.

Commitment to Diversity & Inclusion:
Bristol Myers Squibb is an equal opportunity employer. We embrace diversity, champion equity, and value inclusion in all of our operations.

How to Apply:

For more details and to apply, please visit: Bristol Myers Squibb Careers