Senior Biostatistician

At KCR we recognize that Biostatisticians play a crucial role in healthcare and medical research by applying statistical methods to analyze and interpret data related to biology, medicine, and public health to accurately portray, determine, and drive forward advancement in clinical trials.

We respect that you are passionate about using data to drive critical decisions in healthcare and clinical research. That your years of work within the CRO space means you thrive in an environment where your statistical expertise can make a significant impact.

These are the qualities we are looking for to join our team as a Senior Biostatistician and play a key role in shaping the future of clinical research. If you‘re ready to apply your expertise in statistical knowledge to advance medical research and improve patient outcomes, we want to hear from you.

Location: United States (US); Remote

Applicants must be authorized to work for ANY employer in the U.S.

We are unable to sponsor or take over sponsorship of an employment Visa at this time.

You will be responsible for all statistical deliverables including Statistical Analysis Plans, TLF shells, datasets specifications, data analysis, TLFs outputs and statistical sections for integrated reports. You will closely cooperate with the Head of Biostatistics Team. You will provide leadership and guidance for statistical and programming activities to the team of programmers and junior statisticians within the Biostatistics Team at KCR. This applies to the role of Study Team Lead as well as role of trainer for junior staff. The Principal Biostatistician will provide expert statistical input for protocol development (sample size calculations, data analysis section) and requirements of specific deliverables including DSMB and interim analysis.

Responsibilities:

• Responsible for statistical analysis of all relevant studies;
• Develop Statistical Analysis Plan for conducted studies;
• Create TLF shells and write specifications for Statistical Programmer;
• Provide input for protocol development and develop statistical section of the protocol;
• Review eCRF prior to finalization to ensure design criteria are met and all relevant information to support planned analyses is captured;
• Works as Statistical Team Lead to monitor and review the progress of the statistical deliverables on the assigned studies;
• Responsible for quality assurance of reported results and their statistical interpretation;
• Communicate with clients regarding study protocol and/or statistical analysis issues;
• Develop Biostatistics knowledge by participating in external trainings and self-training;
• Maintain awareness of all statistical guidelines (ICH, EMA, FDA);

Requirements:

• Master’s degree in statistics or equivalent;
• At least 5 years of experience in the pharmaceutical, biotechnological industry or CRO;
• Strong working knowledge of SAS. Basics in R and Python preferred;
• Excellent written and oral English communication skills, including grammatical/technical writing skills;
• Ability to establish and maintain effective working relationships with co-workers, managers and clients;
• Ability to effectively manage multiple tasks and projects;
• Knowledge of CDISC data standards and models;

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits 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:

• A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs;
• Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
• Empowering workspace, with a flat hierarchy, offering opportunities to share ideas and influence company services development worldwide;
• Possibility of getting involved in multinational studies;
• Onboarding process to enable you fast takeover of duties and Buddy Mentor who will introduce you to the organization;
• Open culture based on our values: learning, customer focus, accountability, commitment, tenacity, and determination to succeed;

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

Equal Opportunity Employer

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

If you require reasonable accommodations to participate in the application process, please let us know by email: eeo@kcrcro.com. We are committed to ensuring equal opportunity for all applicants and will work to provide reasonable accommodations to support your needs.

By applying to this position, applicant acknowledges that they have been provided with the above company policies, as well as applicable state and federal regulations and permit contact by the KCR Talent Acquisition team.

***This requisition is not open to solicitation - no agency contact***