This position is somewhat challenge because the requirement is combine both statistical programming and data management experience.
This work must be done onsite at the client.
Design non-CRF data collection specification (client has the template)
Data Management experience in lab data reconciliation using SAS (not the edit check in Rave)
2-3 years Biomarker, PK/PD data experience
At least 4 years strong SAS experience.
Experience on R and Spotfile will be a plus
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.
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 or statistical programming with solid experience in database creation or data analysis. Strong experience in SAS programming and knowledge in Spotfire would be a plus. 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.
BS or MS in Computer Science, Statistics, Public Health, Biology or any other Engineering degree are preferred.
Experis is an Equal Opportunity Employer (EOE/AA)
Product Quality Assurance
Software Quality Assurance (Sqa)