Senior Principal Statistical Programmer

Summary The Senior Principal Programmer is responsible for all statistical programming aspects of several studies a medium to large sized project or project-level activities incl submission and postmarketing activities The position is a key collaborator and strategic partner with biostatistics in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high-quality deliverables Major accountabilities 1 Lead statistical programming activities as Trial Programmer for several studies or as a Lead Program Programmer for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization 2 Co-ordinate activities of programmers either internally or externally Make statistical programming decisions and propose strategies at study or project level 3 May act as functional manager for local associates including providing supervision and advice to these programmers on functional expertise and processes 4 Build and maintain effective working relationship with cross-functional teams able to summarize and discuss status of deliverables and critical programming aspects timelines scope resource plan e g as SP representative in study- or project-level team 5 Review eCRF discuss data structures and review activities ensure project-level standardization which allows pooling and efficient CRT production 6 Comply with company department and industry standards e g CDISC and processes assess and clarify additional programming requirements review develop and influence programming specifications as part of the analysis plans incl CSPD and other project-level strategies 7 Provide and implement statistical programming solutions ensure knowledge sharing Act as programming expert in problem-solving aspects 8 Ensure timely and quality development and validation of datasets and outputs for CSRs regulatory submissions interactions safety reports publications post-marketing activities or exploratory analyses as required in the assigned drug development studies project 9 Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results 10 Maintain up-to-date advanced knowledge of programming software e g SAS as well as industry requirements e g CDISC SDTM ADaM eCTD Define xml attend functional meetings and trainings 11 Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance 12 Act as subject matter expert SME or as assigned lead process improvement non-clinical project initiatives with a focus on programming and analysis reporting procedures Key performance indicators 1 Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers 2 Adequate representation of the Statistical Programming function as Trial Lead Program Programmer in the Clinical Trial Team project level meetings Effectiveness of communication and team behaviors as assessed by the team members 3 Ability and effectiveness in training mentoring and coordinating internal and external programmers assigned to the same study project as assessed by the functional operational manager 4 Ability and effectiveness as a programming representative on non-clinical initiatives Ideal Background State the preferred education and experience level Education minimum desirable BA BS MS or international equivalent experience in statistics computer science mathematics life sciences or related field Languages Fluent English oral and written Experience Professional requirement 1 Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables proven experience in development of advanced MACROs 2 Advanced experience in contributing to statistical analysis plans and or constructing technical programming specifications 3 Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs 4 Good understanding of regulatory requirements relevant to Statistical Programming e g GCP study procedures 5 Proven communications and negotiation skills ability to work well with others globally and influence 6 Experience as Trial Lead Project Programmer for several studies or project-level activities including coordination of team of internal or external programmers on a given study project ability to transfer own knowledge to others 7 Ideally 7 years of work experience in a programming role preferably supporting clinical trials or in pharmaceutical industry Skills Desired Classification Systems Clinical Trials Computer Data Storage Computer Programming Cross-Functional Teams Data Analysis Data Structures Initiative Programming Languages Reporting Statistical Analysis