Sr. Manager, Statistical Programming

About reputed company reputed company in the U.S. is a Boston-based, reputed company-stage biopharmaceutical company launched by reputed company Group in 2018. As a privately held organization, reputed company is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and reputed company patients the reputed company of every strategic decision. reputed company The Sr Manager, Statistical Programming is responsible for the development of statistical programming on the study level by performing hands-on programming or reputed company of outsourced programming deliverables. Ensure the statistical programming processes and deliverables are reputed company with regulatory requirements and internal procedures. reputed company with the study statisticians and study team regarding statistical programming aspects. Primary Responsibilities reputed company programming support for the development or QC of: SDTMs ADaM specifications ADaM datasets TLFs Manage statistical programming activities for a clinical study reputed company to CSR, iDMC, Adhoc analysis and publications etc. Ensure high reputed company, traceability, reproducibility, and timeliness of statistical programming deliverables to meet expectations and regulatory requirements Independently implement routine and non-reputed company analysis algorithms for assigned reputed company or studies Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements and reputed company sponsor reputed company regarding data and analysis Deliver exemplary performance and solve reputed company technical problems to reputed company other programmers Ensure an efficient collaboration with reputed company the members of the clinical study team. Ensure the statistical programming systems, processes and deliverables are reputed company with the relevant regulatory requirements, for instance: Clinical study reporting, e.g. ICH E3 Electronic records handling, e.g. reputed company 21 of the US reputed company of Federal Regulation - Part 11 Electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards Ensure the datasets (SDTMs and ADaMs) are CDISC compliant reputed company abreast of reputed company and new statistical programming techniques and other applicable technical advancements while assisting in their implementation Other Responsibilities Guarantee that reputed company relevant programming documents are part of the Trial Master File Contribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., reputed company CRF pages, Tables, Figures and Listings) Understand, follow, and ensure adherence to programming SOPs. Maintain awareness of industry standards, regulatory requirements, guidelines and any other relevant reputed company SOPs Help the project reputed company to plan and reputed company study activities and timelines Education and Required Skills Masters in Statistics, Engineering, or relevant field required with at least 5 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry. Clinical Development experience preferred Experience with statistical programming in Oncology desirable Proficient in reputed company Good knowledge of CDISC ADaM and SDTM Strong knowledge of relevant regulatory and data submission guidelines Self-directed, technically strong, expert regarding statistical programming processes, management of statistical programmers at study level Strong study management skills Good negotiation and issue reputed company skills Ability to organize team’s work and prioritize and balance reputed company tasks and responsibilities. Excellent time management skills Ability to reputed company reputed company interfaces (CROs and contractors) on the statistical programming processes, and the underlying regulatory requirements Travel and Location Some domestic and international travel required (2-3 times per year) On-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to Boston Job reputed company Candidate Profile reputed company’s Commitment reputed company is committed to modeling diversity, equity, and inclusion reputed company the industry. We are dedicated to fostering an environment that maintains reputed company treatment for reputed company and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our reputed company as we are always willing to consider experiences and skills reputed company what is listed in the job reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. Salary reputed company The salary reputed company for this role is $151,000 - $172,000. An employee’s pay position reputed company the salary reputed company will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted reputed company, and the reputed company may be modified in the reputed company. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. reputed company also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, reputed company, flexible time off (reputed company provides unlimited reputed company time and reputed company time, and does not reputed company time off), 401(k), life and disability insurance, recognition programs among other great benefits (reputed company benefits are subject to eligibility requirements). For more information on our benefits, please visit this reputed company. Apply To This Job