1+ months

Statistical Programmer Analyst

Kelly Services
South San Francisco, CA 94080
Statistical Programmer Analyst

The clinical programmer - is responsible for assisting the lead clinical programmer to:

1. Work with internal study management team members, Bio-sample operation managers and external data vendors to define file format specifications and data transfer specifications for all non-CRF data collection and transfers to internal data operating systems or specific biomarker data repositories.

2. Develop or review the data quality check specifications and generate programs using SAS or Spotfire to check the data quality and flag data issues for both non-CRF and CRF data.

3. Generate visualization report for data quality check or medical data review.

4. Assist lead clinical programmers on any other tasks if needed.

This role requires the Programmer to be technically competent, have excellent customer service skills and a desire to engage customers in pursuit of new business opportunities. The role requires the programmer has extensive knowledge on various source of lab data especially biomarker data. The role also requires the Programmer to be positive, engaged, innovative and professional in their approach to their work.

Job Description

1.Key Accountabilities

The accountabilities of the Clinical Programmer include, but are not limited to:

Understand the nature of non-CRF data and define file format specifications and file transfer specifications following company standard if available.

Ensure the quality of non-CRF data are meeting study needs

Provide programming support to generate sample reconciliation report working with other study management team members and bio-sample operation managers

May work on transformation of the non-CRF data to CDISC standards

_Delivering data transfers (clinical and non-clinical data) in a secure and validated fashion from external sites into USMA and also between USMA Medical Units and groups._

_Support for IXRS, in collaboration with Biometrics colleagues if needed_

_Generating SAE Reconciliation Reports if needed_

_DATA group input to document repositories, such as the migration from LiveLink to Touchpoint._

_Management of structured as well as unstructured data by deploying appropriate systems or databases. As needed, resolve issues surrounding management of data and/or data integrity and/or works with applicable stakeholders to resolve these issues. Creates reports or other functionalities needed to identify and resolve data issues._

_Tracks and highlights data trends, themes, opportunities or issues._

Being compliant with all applicable training, SOPs and Policies impacting the work of Genentech colleagues, in general, and USMA and BDS in particular.

Working collaboratively with Roche-Genentech programming colleagues in other divisions, including gRed, pRed, PD and PDMA.

Work collaboratively with the Data Management Therapeutic Area DMs (Oncology and Non-Oncology)

2.Key Competencies / Experiences

The competencies/experiences of the contractor Clinical Programmer include, but are not limited to:

At least 4 years experience of hands on clinical programming with solid experience in database creation, SAS programming, Spotfire, etc.. Experience with Tableau, R, Python or any other languages is a plus.

Ability to learn quickly and adapt to new environment is highly desirable.

Extensive knowledge and experience on clinical lab data or biomarker data are highly desired

Excellent problem solving and analytical skills.

Excellent verbal and written communication skills.

Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations.

Proven competence of development of software under a Software Development Lifecycle (SDLC).

3.Compliance, Audit and Quality Assurance

The contractor Clinical Programmer will have particular responsibility for:

Ensuring personal compliance to all applicable Roche SOPs, Policies and Compliance documentation.

Keeping personal Training and training records (eg LSO) up to date.

Delivering programming components of internal audits (for instance, PDQA) and external audits (includes FDA and MHRA Audits)

Managing the level of Quality Control (QC) conducted by external vendors (specifically, FSP vendors) and managing QA of the programming deliverables and QC documentation, once it arrives into Evidence Generation.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-12-20 Expires: 2020-02-20

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Statistical Programmer Analyst

Kelly Services
South San Francisco, CA 94080

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