Manager, Statistical Programming

Synteract - USA - Manager, Statistical Programming - Anywhere, US Remote Who We Are Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases. Position Overview As the Manager, Statistical Programming you will function as a member of the Statistical Programming leadership team and manages the day-to-day activities of a team of Statistical Programmers. You will work closely with project teams, Sponsors, and vendors to ensure efficient and high-quality delivery of clinical trials while monitoring timelines, resourcing, and budgets. You will provide mentorship and guidance regarding professional development of the members of their team. You will lead initiatives that improve function and efficiency of the department. Specific tasks would include: Provide on-going feedback and development to support a team of statistical programmers. Document and deliver annual performance reviews. Make recommendations regarding development needs including opportunities for advancement and/or corrective actions. Assist with hiring decisions including interviews and screening of new candidates. Support new employees during their on-boarding period, and provide on-going training thereafter. Ensure adherence to company SOPs, GCP, ICH guidelines, and all applicable local and international regulations. Provide management oversight to a portfolio of studies. Aid study leads with the management of study budgets and timelines, assess and escalate causes of overburn and departures from approved timelines, and assist in negotiating changes in scope with project managers and Sponsors. Provide timely reporting of progress, issues, and concerns to department leadership. Ensure that study teams have adequate resources and support to deliver a timely and efficient product. Support the management of the Statistical Programming function and the Biostatistics and Statistical Programming Department in general. Provide support, comments, and suggestions to aid in development of process (e.g., CDISC, SAS/Macro, etc.).Support the training and development of the Statistical Programming function (e.g., create and deliver training content).Participate in regular management team meetings to analyze/discuss motivation, training, resourcing, budgeting, personnel issues, and process. Ensure regular and accurate updating of resource tools, contribute to discussions of resource assignments, and maximize department utilization while minimizing overburn on projects. Lead and/or support initiatives to support the growth and improvement of the function and/or department. Support communication within and between project teams, offices, and other departments related to delivery of Statistical Programming output. Provide input into the annual budget process as needed (e.g., identify training and development expenses for team members). Qualifications Bachelor or Master's degree in mathematics, statistics, or related field of study and a minimum of 5 years of experience or equivalent combination of education and experience. Specific Knowledge Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. Advanced proficiency in BASE SAS, SPSS or other statistical software. Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends. This job excludes Colorado applicants. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.... - Permanent - Full-time

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