We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move your medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

The position is responsible for statistical programming, including, developing and maintaining standard SAS programs and systems that can efficiently provide timely listings, tables, summary reports and analyses of clinical trial data. This position reports to the Functional Head of Biostatistics.

Essential Functions:

• Perform data analysis and reporting of clinical trial data for both safety and efficacy, including listings, tabulations, graphical summaries and formal statistical estimates and tests utilizing SAS programming.

• Apply CDISC standards when creating SDTM, ADaM datasets and specifications.

• Create and validate analysis datasets, tables, listings, and figures (TLFs).

• Generate complex ad-hoc reports.

• Prepare and validate electronic regulatory submission packages, such as define.xml, Reviewers Guide using Pinnacle 21 Software.

• Apply strong understanding and experience performing analysis for determining early signs of efficacy.

• Assess quality of analysis data, identify and report data issues, perform cross study analyses and create and use/write SAS macros to automate programming functions. Provide technical planning to include overseeing the set-up of key macros and SAS program.

• Estimate programming scope of work, manage resource assignments, communicate project status and negotiate project timelines for deliverables.

• Interact with Sponsors as the key contact with regard to statistical programming issues.

• Responsible for the validity and quality of all statistical reports and deliverables for assigned projects.

• Work collaboratively with internal groups such as Data Management, Biostatistics, and Project Management to meet Sponsor deliverables.

• May have direct oversight and mentoring responsibilities for other statistical programmers.

• Perform other related duties as assigned.

Job Requirements:

• Bachelor’s degree in Statistics/Biostatistics or Computer Science or related field is required, with Master’s degree preferred. Equivalent work experience may be substituted for education at TD2’s discretion.

• Minimum 5 years’ of industry working experience in statistical programming in clinical trials in the biopharmaceutical industry.

• 5+ years’ proficiency in SAS programming.

• Experience in early phase oncology trials preferred. Experience in other complex therapeutic areas, such as rare and orphan diseases, cardiac or AME trials may be substituted at TD2’s discretion.

• Hands-on experience in all statistical programming tasks.

Required Specialized/Technical Skills:

• Advanced knowledge of SAS including Base, SAS/STAT, SAS/GRAPH and Macro Language.

• Working knowledge of statistical methods used in this industry and SAS statistical procedures.

• Proficiency in SAS programming to produce ad hoc tables, listings and figures. Experience with other statistical software such as R a plus.

• Thorough knowledge of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory submissions.

• Knowledge of the drug development process, from early to late stage.

• Ability to manage multiple tasks with competing timelines.

• Excellent communication and interpersonal skills.

• Client focused approach to work.

• Ability to train and lead the work of others.

• Solution oriented, attention to detail, interest and ability to perform in a high-demand and dynamic working environment.

• Possess strategic thinking, contingency planning, problem-solving and dispute resolution skills.

• Ability to quickly find common ground and solve problems.

• Able to travel (10%-15%) as needed.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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