Remote (Country) Full-time

Bristol Myers Squibb is hiring a Senior Manager Statistical Programming

About the Role

At Bristol Myers Squibb, we are dedicated to transforming patients’ lives through science. We are seeking a Senior Manager of Statistical Programming, an individual contributor who will provide comprehensive programming expertise to lead statistical programming efforts for clinical project teams. In this role, you will be responsible for the design, development, and implementation of technical solutions for integrating, analyzing, and reporting clinical data, supporting our product development from research through regulatory approval.

What You'll Do

  • Provide programming leadership and support to clinical project teams and vendors, deploying strategies, standards, and programmed analysis to meet regulatory and procedural requirements.
  • Independently develop, validate, troubleshoot, and maintain complex programs and utilities.
  • Lead or support the preparation and review of electronic submissions.
  • Develop unambiguous and robust programming specifications, such as ADaM specifications.
  • Review key planning documents to ensure clarity and completeness of programming requirements and assess their impact.
  • Communicate proactively around issues and risks and contribute to remediation.
  • Identify, lead, and support opportunities to enhance processes and technology.
  • Develop collaborative relationships within Global Biometrics & Data Sciences (GBDS), with external vendors, and cross-functional teams.
  • Proactively plan, implement, and identify issues/risks, providing strategies to facilitate decision-making.
  • Lead and support the change management process.

What We're Looking For

  • Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences.
  • At least 7 years of programming experience in the pharmaceutical/biotech industry, including support of significant regulatory filings.
  • Proficient knowledge of drug development, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology.
  • Broad expertise in statistical programming and developing computing strategies.
  • In-depth understanding of clinical data structure, including CDISC standards, and relational databases.
  • Demonstrated proficiency in using SAS to produce analysis datasets and TFLs.
  • Proficiency in other software tools and applications: MS Office, XML, Pinnacle 21.
  • Demonstrated ability in processing upstream clinical data and providing deliverables for downstream requirements like ADaM, TFLs, and e-submission components.
  • Demonstrated ability to work effectively in a team environment.

Technical Stack

  • SAS
  • MS Office
  • XML
  • Pinnacle 21

Team & Environment

You will work within Global Biometrics & Data Sciences (GBDS), collaborating closely with external vendors and members of cross-functional development teams.

Benefits & Compensation

  • Compensation range: $145,320 - $176,099.
  • Medical, pharmacy, dental, and vision care.
  • Wellbeing support including the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, and supplemental health insurance.
  • Work-life programs include paid national holidays, optional holidays, Global Shutdown Days, up to 120 hours of paid vacation, up to two (2) paid volunteer days, sick time, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services including adoption/surrogacy reimbursement, fertility benefits, and child/elder/pet care resources.
  • Other perks like tuition reimbursement and a recognition program.

Work Mode

This is a remote position open to candidates within the United States.

Bristol Myers Squibb is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support.

Required Skills
SASMS OfficeXMLPinnacle 21Statistical ProgrammingClinical TrialsCDISC StandardsSDTMADaMRegulatory SubmissionsProject ManagementTeam LeadershipBiotechnology/Pharma
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About company
Bristol Myers Squibb

Bristol Myers Squibb is a biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases.

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Posted 5 months ago