Clinical data management programmer Jobs

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Biostatistical Programming Manager
Amgen —Hyderabad, Telangana
Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory…

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Principal Statistical Data Scientist

Pfizer -
Chennai, Tamil Nadu

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Job details

Full-time

Qualifications

Statistics
Statistics
Computer Science
SAS
R
Master's degree
Project management
Bachelor's degree
Clinical trials
Communication skills
Python

Full job description

An Individual Contributor role

Productive hands on programming, supporting deliverables in the study/project/portfolio/standards team, of medium – high complex statistical programming deliverables to support assets and study teams

Performs tasks independently with mentorship or advise from Programming Leads within the organization

Acts as co-lead/lead on selected projects/initiatives/activities and also study deliverables as needed.

Guide, mentor, monitor programmers within the team and collaborate with SDSL’s on timelines, resource management and deliverables with quality.

Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones

Ensures adherence to high quality programming standards in their daily work

Ensure the tasks are completed on time with quality and are compliant to the process at with needed guidance.

Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.

Active self-learning and delivering on solutions in the space of statistical programming and data standards

Contribute to SDSA initiatives globally and locally.

Job Responsibilities

Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team

Accountable for their assigned work supporting the standards/study deliverables and also to assist SDSL’s with the team assignments.

Review/Develop/Validate/Review datasets, TFL as per CDISC aligned Standards or Data Standards for Study/Project/Portfolio. (Portfolio)

Contributes to upto 80% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python and 20% to self learning, development and growth.

Explore the existing code base and execute/perform runs as required, also develop/modify as per the needs and specifications suggested to the standards team as appropriate – (Standards Programming)

Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables across Standards, Programming and Submissions.

Understand/Implement standard/study/project/portfolio requirements and specification and work with global stakeholders in ensuring completion of project/study/deliverable goals and milestones

Knowledgeable in core safety standards as well as TA standards pertinent to their project and lead development of standards necessary for their study

Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.

Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning

Support in accomplishing department and organization mission by completing assigned tasks

Acts as mentor to junior team members

Advances job knowledge to next level by participating/contributing in/to opportunities both globally and locally.

Basic Qualifications:

Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field.

At least 5 - 6 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.

Understanding of clinical data and drug development process, CDISC standards required

Statistical Programming and SAS hand-on experience

Clinical trials expertise with an understanding of data operations required for the reporting of clinical

Good understanding of ICH and regulatory guidelines

Working knowledge of clinical data and relevant data standards

Is able to work with stakeholders across timezones under tight timelines

Strong written and oral communication skills, and time and project management skills

Strong competencies and interests for innovation and problem solving

Proven ability to operate with limited oversight

Knowledge of at least 1 Therapeutic Area

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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