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23 days old

Senior Manager, Biostatistics - REMOTE

Kelly Services
New York, NY 10176 Work Remotely
**Job Title:** Senior Manager, Biostatistics - REMOTE


**Location:** US


**Reports to:** Senior Director, Biostatistics and Data Management


**P** **OSITION S** **UMMARY:**


Seeking a highly qualified Senior Manager, Biostatistics who will oversee Contract Research Organization (CRO) vendors for biostatistical and programming activities in support of Phase I - Phase IV clinical trials. The successful candidate will become a member of the Clinical Development (CD) department and is responsible for providing guidance to the CD team regarding trial design, endpoint selection, statistical analysis, and vendor selection for IAVIs clinical trials. The Senior Manager, Biostatistics is also responsible for managing timelines relating to key milestones and ensuring outsourced work is performed with high quality. This position will contribute to supporting the Clinical Development departments work and IAVIs mission.


**K** **EY R** **ESPONSIBILITIES:**


+ Provide oversight of outsourced biostatistical activities, coordination with other functional areas, and management of overall timelines, resources, and quality.

+ Oversee biostatistics and programming-related responsibilities, including protocol development, trial start-up, randomization specifications, case report form (CRF) development, statistical analysis plan (SAP) and table shells development for interim and final analyses, statistical programming, safety reporting, Clinical Data Interchange Standards Consortium (CDISC) compliance, and all associated documentation for electronic trial master file (eTMF) filing.

+ Act as a liaison between biostatistics vendors and the CD team, in particular Medical Monitors, Clinical Operations, and Data Management, by providing guidance on biostatistical aspects of clinical trials, such as randomization, CRF design, SAP development, safety reporting, resourcing, timelines, metrics, and other biostatistical support.

+ Maintain biostatistics-related eTMF materials for clinical trials.

+ Ensure CDISC/CDASH standards are applied by vendors and maintain a global CRF library appropriate for all clinical trials.

+ Oversee biostatistical workflow of IAVI-contracted CROs to maximize efficiency across all clinical trial biostatistics-related deliverables.

+ Develop and review external (third party) data transfer agreements; consult with CROs to integrate external data into study programming process flow.

+ Review SDTM and ADaM dataset specifications to ensure conformity to CDISC implementation guidelines and standards, as well as SDTM and ADaM datasets prepared by CROs to ensure consistency with dataset specifications.

+ Provide/facilitate support as needed (technical, clinical) to ensure efficient action, collaboration and resolution of biostatistical issues.

+ Assist QA team in performing vendor audits, as required.

+ Write and revise relevant departmental Standard Operating Procedures (SOPs).

+ Ensure compliance with departmental SOPs.


**E** **DUCATION AND W** **ORK E** **XPERIENCE:**


+ MS or MPH degree in Statistics, Biostatistics, or related field is required.

+ Minimum 7 years of experience in the pharmaceutical industry (biotech, pharmaceutical company, CRO) in Biostatistics and SAS programming (Base SAS, SAS/STAT, SAS/GRAPH and SAS macro language).


**Q** **UALIFICATIONS AND S** **KILLS:**


+ Design and analysis of safety, immunogenicity, and/or efficacy endpoints for early to late-stage vaccine trials are required.

+ Vendor oversight of programming and statistical deliverables is required.

+ Experience developing SAS macros, database retrieval for data review and statistical programming, CDISC standards for programming of derived datasets, and using the SAS Output Delivery System to output tables, listings and figures is required.

+ Experience with various eDC platforms (e.g., Medidata Rave, IBM eClinical), along with tools such as eCOA/ePRO, eDiary, and IWRS as applied to clinical trials is required.

+ Proven ability to be innovative, set realistic timelines, and provide leadership as part of a clinical study project team is required.

+ Proven ability to implement GCP guidelines is required.

+ Flexibility to change priorities and be comfortable with changing deadlines to meet organization needs is required.

+ Attention to detail, with the ability to work on multiple projects with overlapping schedules and priorities is required.

+ Ability to work independently, as well as in a team, while exercising discretion, is required.

+ Solid knowledge of EMA and ICH regulations, CDISC, and FDA guidance is required.

+ Proven track record of reviewing and understanding study protocols, SAPs, and other clinical related materials is required.

+ Taking initiative to resolve problems is required.

+ Solid knowledge of WHODrug and MedDRA coding dictionaries is required.

+ Knowledge of current technological developments/trends in clinical trial design and statistical methodology is required.

+ Excellent verbal and written communications skills are required.

+ Excellent computer literacy skills with expertise in Microsoft Office are required.

+ Experience with preparing statistical analyses (e.g., CSR, ISS, ISE) for regulatory submission is desirable.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-24 Expires: 2021-04-26

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Senior Manager, Biostatistics - REMOTE

Kelly Services
New York, NY 10176

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