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Senior Manager or Associate Director, Biostatistician

Hiring Senior Manager/Associate Director Biostatistician for Small Pharmaceutical company in San Francisco bay area.

Responsibilities
• Lead in product / indication level tasks and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
• Contribute in study level tasks from statistics perspective, including: Contribute in study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TLG shell and specification Review CRFs and other study documentations; Active participation in study related meetings
• Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Contribute in developing standards and research in advanced statistical methodologies
• Author/review regulatory documents or scientific publications
• Mentor junior team members

Requirements
• Masters/PhD in Statistics or Biostatistics with a minimum of 8 years of post-graduate experience in the clinical trials setting (min 5 years for PhD), preferably in the pharmaceutical industry, either with a sponsor or a CRO
• Proven experience as product lead statistician and contribute in strategy discussion in cross functional settings
• Demonstrated ability to manage multiple products and studies with prioritization
• Experienced in study level work including authoring SAP and TFL specification
• Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
• Solid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferred
• Good communication and interpersonal skills, with the ability to translate statistical concept to program / study strategies
• Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according company timeline
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

Clinical Data Manager (Senior Manager Level)

We are helping a small pharmaceutical company to hire a Senior Manager Data Manager position. The company is located in Novato, CA, 25 miles north of San Francisco.
Responsibilities
• Operational leadership of data management activities for one or more programs.
• Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
• Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed.
• Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.
• Facilitate cross-functional sponsor review meetings of eCRF design and edit check specifications. 
• Facilitate and perform cross-functional sponsor EDC user acceptance testing.
• Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting.
• Facilitate the development and implementation of key data and metrics reports/listings.
• Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Data Management Plans and DB Go Live and Lock documentation.
• Contribute to Data Management department infrastructure, by leading/contributing to SOPs development, CRF standards development and cross-functional process improvement initiatives.
o Contribute to development of DM outsourcing strategy through the identification, evaluation and selection of key CRO partnerships.
o Contribute to the evaluation, selection and implementation of novel electronic data capture solutions. 
Requirements
• Bachelor’s degree or higher in the scientific, biological, statistical or computer science field or related discipline.
• Minimum ten years of clinical trial data management experience in the pharma/biotech industry.
• Strong experience in CRO and vendor management with consistent track record of on-time quality deliverables.
• Extensive technical experience using electronic data capture systems. EDC database development experience a plus. 
• In-depth knowledge of DM industry standards, best practices and CDISC/CDASH implementation.
• Ability to adapt and manage competing and rapidly changing priorities.
• Effective in proactively identifying issues and driving team towards creative solutions and smart decisions.
• Ability to create strong, collaborative working relationships. Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment
• Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook).

Senior SAS Programmer

Statistical Programmer II permanent position in a Pharmaceutical company in Novato, CA. 
Responsibilities
• Responsible for the development, review, validation, and execution of SAS programs to generate Tables, Figures, and Listing
• Create and review annotated CRF to SDTM datasets
• Responsible for the translation of the SAP into programming specifications for analysis data and model (ADaM) datasets
• Review key study-related documents produced by other functions, such as case report forms
• Responsible for reviewing the DMP, SAP and the TFL specifications, and provide feedback to the statisticians
• Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets to be included in reports for submission to regulatory agencies, publications, and other communications
• Experience in developing SAS macros to standardize the workflow and internal processes
• Help with SAS Programming Infrastructure including the design, creation and validation of global SAS macros and utilities that streamline operations to increase programming efficiency
• Support the development of statistical programming processes to ensure the best quality of the statistical outputs.
• Manage the programming activities on multiple projects/studies across various therapeutic areas, both internally and externally by CROs.
• Provide support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company’s strategic objectives
• Function as a positive role model for setting high expectations for quality, creativity and project ownership.
• Works collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers). 
• Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
• Involved with the strategy for process improvement.
• Identify new tools to increase efficiency and quality.

Requirements
• Master’s Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
• Minimum of 3-5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
• Advanced SAS programming skills and experience in other statistical software 
• Proven experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programing projects.
• Excellent organizational skills and ability to prioritize tasks.