AdvertisementManager Biostatistics (PL)
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas.
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A Boutique Contract Research Organization (CRO), with over 20 years of presence on the international market, operating across 4 Regions: US, Western/ Central/ Eastern Europe & Russia is seeking to employ Biostatistics Manager.
The new incumbent will gain an opportunity manage KCR’s Biostatistics department and services in a role of Functional Area Leader for Biostat, Customer communication for Biostat services and delivery of biostatistical knowledge in international projects.
This is a permanent position in one of the company's Operational Hubs in Warsaw (PL).
The duties associated with the role include:
- Management of KCR Biostatistics department and services (role of Functional Area Leader for Biostat) by creating appropriate processes, procedures, roles in the organization
- Line Management for Stat programmers and close cooperation with experienced KCR Statistical consultants
- Customer communication for Biostat services
- Delivering of biostatistical knowledge including: Statistical Analysis Plans, table shells, programming and table specifications, data analysis, TLFs and statistical sections for integrated reports
- Responsible for statistical analysis of all relevant studies in KCR portfolio
- Creation and maintenance of Standard Operating Procedures fulfilling all relevant industry guidelines
- Statistical Analysis Plans development for conducted studies
- Providing input for protocol development and developing statistical section of the protocol, including choice of design and sample size calculation
- Coordination and reviews of eCRF prior to finalization to ensure design criteria are met and all relevant information
to support planned analyses is captured
- Coordination and reviews of SDTM deliverables, including mapping specifications, datasets, and annotated CRFs
- Close cooperation with Data Management and Data Analytics Teams and providing support when needed
- Creation of templates for study reports and precise specifications for the Statistical Programmers, in line with Statistical Analysis Plan.
- MSc or educational equivalent in biostatistics or related field
- At least 3 years of professional experience in expert or managerial role
- Excellent computer skills: strong working knowledge of SAS and/or R computing packages
- Excellent written and verbal English communication skills including grammatical/technical writing skills
- Attention to details
- Ability to effectively manage multiple tasks and projects
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Ability to work independently and efficiently according to local regulations, SOPs, ICH GCP, GVP, EU Directives
that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with:
- 3-step onboarding process to enable you fast takeover of duties
- Peer Buddy Mentor who will introduce you to the organization
- Friendly office space, coffee, tea and sweets
- Flexible, remote working options
- Time off – additional days of holidays for birthday, leaves of absence
- Loyalty bonus for long term cooperation
- Employee referral program
- Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
- Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
- Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development