Purpose of the position

This position supports the Data Management and Biostatistics Team to ensure that all project data is analyzed and subjected to the required statistical tests based on the protocol and study designs and that final consistency checks on the data is done to assure its validity and completeness before any analysis can take place.

Specific Job Responsibilities

• Contribute to the design of the study protocols including sample size estimation and power analysis.
• Perform random number generation and patient allocation for RCT.
• Develop Statistical Analysis Plans (SAP), TLF shell and dataset specifications for SDTM and ADaM.
• Be an SDTM and ADAM expert providing advice and training.
• Writing analysis programs to meet specifications of the SAP/lead statistical programming activities as trial programmer as well as making statistical programming decisions/recommendations at study/project level.
• Maintain proficiency in SAS and awareness of developments.
• Identify areas where new processes are required as well as create, review and update SOPs and Study Specific Procedures (SSPs).
• Analyzing and interpreting data from clinical trials and other studies.
• Liaise with the Senior Manager, Data Management and Biostatistics and coordinating office (Regional Operations Manager) to develop quarterly and yearly work-plans to determine activities and targets for the period.
• Identify and resolve data discrepancies in liaison with data managers.
• Participate in validation of Clinical Data Management Systems including edit check programs.
• Support study team in developing data collection tools and preparing data entry templates.
• Contribute to Case Report From (CRF) design and all other data management and statistical documentation.
• Perform additional management activities as required to provide timely and high-quality data for the purposes of analysis and/or regulatory submissions, database creation and testing.
• Maintain strict confidentiality of all privileged information regarding data and the organization.
• Assist in writing the statistical section of the CSR and ensure the CSR accurately describes the statistical methods and results of analyses.
• Ensure appropriate analysis procedures are used in statistical analyses.
• Create case report tabulations (CRT) from clinical trial data.
• Ability to work on multiple projects, plan, organize and prioritize activities.
• Be aware of up-and-coming changes to regulatory guidelines/requirements and awareness of emerging standards and associated impact to ongoing and future planned trials.
• Build and maintain effective working relationships with cross-functional teams.
• Comply with organization and industry standards (e.g. CDISC) and processes.
• Mentor other staff on statistical analysis/statistical programming.

Reporting line

• This position reports to the senior biostatistics manager.
• Close working relationship with the Senior Management Team.

Job Requirements

Skills and Attributes

• Proficient SAS programming skills.
• Excellent knowledge of and experience with CDISC standards (e.g., programming of SDTM and ADaM datasets, both production and validation).
• Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.
• Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
• Strong communication skills in multicultural, multi-lingual environments
• Strong ability to work effectively as part of a multicultural team.
• Well organized and structured.
• Strong analytical skills and ability to critically review data.
• Strong ability to provide high level support in project/program delivery.
• Strong ability to manage medium/large projects with budget management.
• Strategic thinking and leadership abilities.
• Strong management, negotiation, and advocacy skills.
• Has autonomy for taking actions and decisions.
• Strong ability to interact with external stakeholders.
• Lead and motivate a small team for optimum performance, supervising junior staff.
• Thorough knowledge of and experience with CDISC standards is desired.

Experience

• Over 5 years of CRO/Pharma industry
• Proven ability to work effectively in a team environment and matrix structure.
• At least 3 years’ experience in managing large amounts of data, including writing data validation and consistency checks. Previous work on multi-centre clinical trials would be an added advantage

Education

• BSc Statistics with MSc in Statistics or related field

Other information

• Status: Fulltime contract