Senior Statistical Programmer

2 days ago


Central Singapore Emprego SG Full time

**Location**

Singapore, Central Singapore

**Job Type**

Permanent

**Salary**

$9,000 - $10,000 Per Month

**Date Posted**

8 hours ago

Additional Details

**Job ID**

3163

**Job Views**

2

Roles & Responsibilities

My client, a US MNC whom is a leading Healthcare IT software company is looking out for a competent Senior Statistical Programmer to support their company's growth to new levels:
**Requirements**:

- Lead, or contribute to, statistical programming activities on PBS projects (development or QC of deliverables):

- delivering exemplary performance and solving complex technical problems to inspire other programmers,
- ensuring an efficient collaboration with PBS global teams (Europe, India, and US)
- being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
- being accountable for overall client satisfaction with these deliverables,
- maintaining a detailed project and validation plan,
- efficiently communicating with internal and external clients,
- ensuring budget monitoring and adherence
- Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:

- Clinical study reporting, e.g. ICH E3
- Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
- Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards
- Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers )
- Understand, follow and ensure adherence to all BDM SOP as well as any other relevant SOPs.
- Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation

**Qualifications**:

- BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)
- 8+ years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development, with 2+ years of CRO experience
- Experience as a lead statistical programmer on several concurrent projects
- Strong SAS programming skills
- Strong CDISC ADaM and SDTM- production/validation.
- Good understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
- Good knowledge of relevant regulatory and data submission guidelines.
- Project management skills
- Fluent in English (French and/or German is a plus)
- Ability to work effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups, excellent team player with strong interpersonal skills contributing to building the team spirit
**How to Apply**

Consultant: Tan Jun Jie
EA personnel reg. no.R1878852
EA License No. 17C8502

Tags

senior

statistical

programmer

med

tech

mnc

up

to

sgd10000

mth



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