Associate Director Statistical Programming Cytel Software
Department: Biostatistics and Data Management
Reports to: Global Head of Statistical Programming
Location: Waltham, MA, USA
Cytel Inc. is a leading provider of clinical research services and trial design and analysis software/services primarily for the biopharmaceutical, medical device, academic and government researchers. All 25 leading global biopharma companies and over one thousand specialty developers, leading university and government-sponsored research centers use our technology in their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial we've designed has been accepted by regulators. We're also increasing known for our cutting-edge clinical data handling techniques and management strategies.
Cytel is an equal opportunity employer with a work environment that supports both training and mentoring within the company.
As member of the Biostatistics and Data Management (BDM) department, and reporting to the Global Head of Statistical Programming, the main responsibilities of the Associate Director Statistical Programming will be to:
Contribute to the development of a strong team of statistical programmers in the US, by functionally managing local programmers with respect to statistical programming strategy, deliverables, processes, and professional development:
Provide leadership in promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.
Provide leadership in balancing conflicting priorities.
Lead, or contribute to, statistical programming activities on BDM projects (development or QC of deliverables):
delivering exemplary performance and solving complex technical problems to inspire other programmers,
ensuring an efficient collaboration with BDM teams in Europe and India,
being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,
being accountable for overall client satisfaction with these deliverables,
maintaining a detailed project and validation plan,
efficiently communicating with internal and external clients,
and ensuring budget monitoring and adherence
Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
Clinical study reporting, e.g. ICH E3
Electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers?)
Understand, follow and ensure adherence to, all BDM WIs/SOP as well as any other relevant WI/SOPs.
Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
When needed, interact with regulatory agencies regarding specifications for electronic submissions, and direct/develop statistical programming electronic submission deliverables.
Occasionally, responsibilities will also include to:
Contribute to budget evaluation for proposal writing purpose.
Lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.
Contribute to the design, creation and validation of global macros or systems that streamline operations to increase programming efficiency.
BSc or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)
Fluent in English (French and/or German is a plus)
Professional Experience & Technincal Skills
Preferably at least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development
Preferably 2 years of experience as a statistical programming team leader or manager
Consistent experience as a lead statistical programmer on several concurrent projects
Proficient in SAS
Good knowledge of CDISC ADaM and SDTM.
Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
Strong knowledge of relevant regulatory and data submission guidelines.
Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management.
Strong project management skills
Ability to work effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups, excellent team player with strong interpersonal skills contributing to building the team spirit
Ability to rapidly understand and anticipate the needs of internal and external customers, and respond to their inquiries
Good negotiation and issue resolution skills
Ability to organize team work and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills
Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements
Strong mentoring skills
Compensation & Benefits
Cytel offers a competitive salary-based package, stock options, comprehensive medical and dental benefits, plus a contributing 401K plan.
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