Manager, Statistical Programming
| Dyddiad hysbysebu: | 14 May 2024 |
|---|---|
| Oriau: | Full time |
| Dyddiad cau: | 13 June 2024 |
| Lleoliad: | Uxbridge, London |
| Gweithio o bell: | Hybrid - gweithio o bell hyd at 2 ddiwrnod yr wythnos |
| Cwmni: | Bristol-Myers Squibb |
| Math o swydd: | Permanent |
| Cyfeirnod swydd: | R1580635 |
Crynodeb
Position Summary
Provide comprehensive 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 integrating, analyzing and reporting clinical data. Senior Statistical Programmers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
Direct Reports
None. Possible contractors/leased workers.
Vendor Oversight
Yes
Key Business Partners
Internal/external stakeholders, project team members, vendors
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
Independently leads and / or performs programming assignments with minimal supervision
Support improvement initiatives
Skills, knowledge, and experience
Minimum Requirements:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
5 years programming experience in industry recommended.
Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
Have 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.
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 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
Oncology experience
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
Provide comprehensive 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 integrating, analyzing and reporting clinical data. Senior Statistical Programmers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
Direct Reports
None. Possible contractors/leased workers.
Vendor Oversight
Yes
Key Business Partners
Internal/external stakeholders, project team members, vendors
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
Independently leads and / or performs programming assignments with minimal supervision
Support improvement initiatives
Skills, knowledge, and experience
Minimum Requirements:
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
5 years programming experience in industry recommended.
Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
Have 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.
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 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
Oncology experience
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