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Biostatistical Programming Mgr

4 weeks ago


Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

In this vital role, you will be a Biostatistical Programming Manager responsible for leading a team that manipulates large databases and generates reports to produce Real-World Evidence (RWE) from real-world healthcare data assets. The ideal candidate will possess strong statistical programming skills, managerial experience, and a deep understanding of the drug development lifecycle. You will provide technical solutions to programming problems, manage a team, and ensure that all programming activities adhere to departmental standards and SOPs.

Responsibilities

- Technical Leadership & Project Management: Provide technical solutions to programming problems within the Centre for Observational Research (CfOR). You will lead and develop technical programming and process improvement initiatives, project manage programming activities, and oversee the work of outsourced resources.
- Team & Staff Management: Manage staff performance, oversee staff assignments, and participate in the recruitment of programming staff. You will also represent the programming function in multidisciplinary project team meetings.
- Programming & Validation: Write, test, and validate software programs in Unix to produce analysis datasets and presentation output. You will write, test, validate, and execute department-, product-, and protocol-level macros and utilities.
- Documentation & Compliance: Write and/or review and approve programming plans, analysis dataset specifications, and key study-related documents. You will ensure programming activities adhere to departmental standards and SOPs and will participate in study and systems audits.
- Collaboration & Innovation: Actively participate in intra-departmental and CfOR meetings, contributing to the continuous improvement of programming and R&D. You will collaborate with epidemiologists and other functions to drive RWE generation.

Qualifications

- A Master's degree with 4-6 years, a Bachelor's degree with 6-8 years, or a Diploma with 10-12 years of experience in a relevant scientific subject such as Computer Science, Statistics, or Life Sciences. A Doctorate degree is also accepted.
- A minimum of 6 years of relevant career experience in statistical programming.
- Managerial experience directly managing people and/or leading teams is preferred.
- Proficiency in SQL programming and SAS or R is required; Python is preferred.
- Experience with Real-World Evidence (RWE) generation in pharmaceutical or related research industries.
- Experience working with real-world healthcare data (RWD) such as claims databases (MarketScan, Optum Clinformatics, Medicare) and EHR databases.
- Training or experience using the OMOP common data model is a plus.
- An understanding of statistics and basic epidemiology is essential.

Skills

- Technical: Hands-on programming and a lead role. You should have expert statistical programming knowledge using SAS or R, and experience with SQL.
- Communication: Excellent verbal and written communication skills in English, with the ability to have efficient exchanges with colleagues across geographical locations.
- Leadership: Strong leadership, teamwork, and innovation skills, with the ability to manage a team and drive initiatives.
- Problem-Solving: Excellent problem-solving abilities and meticulous attention to detail.
- Project Management: Experience with Agile project management is required.