Job Description

:Brief Position Description:The Senior Statistical Programmer II (SSP II) is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies and, if applicable, for data submission packages to client and regulators. The SSP II can act as Statistical Programming Team Lead (SPTL) managing and supervising the work of statistical programmers assigned to the Team dealing with a portfolio of projects. The SSP II works closely with the project biostatisticians and other project stakeholders.Minimum Qualifications & Experience:Minimum bachelor's degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in quantitative/analytical field with a minimum 7 years of experience in Pharmaceutical industry, CRO or related experience using SAS programming in clinical studies, including leading a clinical study or project programming team. Able to independently perform technical work. Exceptional SAS programming skills. Knowledge of CDISC standards and applying standards to different study phases, study designs and therapeutic areas.Responsibilities:1. Projects/Clinical Studies

• Review a clinical study protocol with regards to statistical programming responsibilities.
• Assess study related workload and project timelines and discuss programming time estimates and risk mitigation plans with Statistical Programming Team Lead for inclusion in resource forecasts.
• Review and provide input to a Statistical Analysis Plan (SAP) with respect to presentation of data and results (tables, listings, figures).
• Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects.
• Undertake peer review of SDTM and ADaM or analysis datasets specifications from junior staff as required.
• Program SDTMs, ADaMs or analysis datasets, tables, figures, and listings (TFLs) according to approved specifications.
• Adhere to company statistical programming standards and conventions, and data standards.
• Ensure that SAS programs generated for data storage, transformation, presentation and statistical analysis are properly documented and traceable.
• Assess requests for changes to SAP, Tables, Listings, Figures, and SDTM/ADaM or analysis datasets specifications, and discuss with Statistical Programming Team Lead for inclusion in resource forecast and change orders (Change Management).
• Participate in audits.
• Maintain study documentation, programs and files within project files and maintain timesheets.
• Represent Novotech at client meetings as required.

2. Clinical Product Development

• Undertake gap analysis across the clinical study databases that need to be part of the data package with respect to the standardization and transformation efforts required.
• Develop project plan to generate the package and estimate costs in consultation with Line Manager and Biostatistics.
• Develop programs to generate SDTM datasets, SDTM annotated CRF, AdaM datasets, Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission.

3. Section

• Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
• Mentor junior staff in technical matters and assist in induction of new staff.

4. Software and Programming Tools

• Contribute to developing company programming conventions and SAS macros.
• Assess impact of new software releases and patches of SAS on ongoing projects.
• Contribute to automating statistical programming tasks and progress tracking.
• Advise Clinical Data Management and Clinical Data Programming with respect to CRF libraries and data dictionaries based on CDASH and SDTM.

5. Statistical Programming Processes and SOPs

• Contribute to the development and updating of SOPs and best practices, process improvement, quality control and governance related to all statistical programming matters.
• Ensure compliance with applicable regulatory agency guidelines and Novotech's corporate policies and SOPs, and SOPs for study design, protocol development and all other statistical programming output.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.About Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

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