Manager, Statistical Programming

Location

Secunderabad | India

Job description

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 data sets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis d atasets 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 revi e w

• 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 programmi ng assumptions and requirements ; Assesses impact on programming activities

• Interacts with vendors regarding project standards, programming conventions, programming spec ifications and file transfers

• Provides leadership for ensuring quality of Global Biometric and Data Sciences ( GB D S) deliverables by consistently applying s tandards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work p ractices

• Identifies opportunities for increased efficiency and consistency within GB D S and our interactions with strategic vendors

• Independently leads and / or performs programming assignments with minimal supervision

• 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 deriv ed analysis datasets and TFLs.

• U nderstanding of clinical data structure ( e.g. CD I SC standards) and relational database.

• Demonstrated skills in using software tools and applications, e.g., MS office, XML.

• Demonstrated ability in the handling and processing of upstream data, e.g., multiple d ata 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 environm ent with clinical team members.

Preferred Requirments :

• Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development
• 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

Job tags

Salary