Vp, Biostatistics

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**The Company**

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

**Why Us?**
- It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact
- Everything we do - and we do it with passion - is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
- We’re growing, and so will you with leaders who will support your development through mentorship and other opportunities
- Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

**The Role**

The Vice President (VP) Biostatistics is responsible for leading the Biostatistics Department and provide statistical mentorship, expertise and business excellence for the design, development, analysis, interpreting, reporting, and presentation of for Phase I, Phase II-III, and BA/BE studies

**You Will Have The Opportunity To**:

- Manage the Biostatistics Department, including statisticians and statistical programmers.
- Manage personnel resources and workload ensuring optimization of departmental gross margin.
- Recruit, attract and maintain a high-caliber statistical personnel, develop and mentor the team members.
- As necessary utilize and oversee activities of consultants and 3rd party vendors.
- Serve as the key expert for Phase I, Phase II-III and BE/BA biostatistics.
- Design, plan and direct the statistical activities in ensuring compliance with all applicable laws, SOP’s, and regulatory requirements.
- Communicate with clients regarding study requirements, study protocol, clinical conduct, statistical questions, and safety related to study design and analysis.
- Support Business Development and attend sponsor meetings.
- Participate in and support project teams on achieving client satisfaction through delivery of quality statistical design, planned analysis, and statistical output.
- Maintain up-to-date statistical knowledge within area of expertise and ad hoc therapeutic areas via periodic literature review and conference attendance.
- Responsible for leading, guiding and implementing statistical standards that meet regulatory and industry expectations.
- Responsible/involved with the annual departmental budget planning.
- Ensure the compliance with FDA/TPD/EMA regulations and maintain superior inspection results from all authorities and regulating agencies in the department.
- Represent company in scientific conferences and various pharmaceutical associations, working groups, and regulatory related meetings for BPSI’s professional expertise and business development.
- Increase the company scientific/statistical exposure by presentation at conferences and publication on peer reviewed scientific journals.

**What You Will Bring**:

- MSc or PhD in statistics or related field
- A minimum of 7 years of experience in clinical trials design and data analysis
- Strong management and leadership skills
- Excellent understanding of Phase I statistics and CDISC requirements
- Extensive experience in literature evaluation and scientific support
- Proven abilities in scientific writing, publications in medical/pharmaceutical journals
- Pronounced critical thinking with strong attention to detail
- Strong orientation to provide guidelines, advice and support, to mentor and establish practices and procedures for projects and teams
- Excellent organizational skills and ability for deadline-oriented coordination of activities within a team
- Ability for balanced scientific judgment and client-oriented thinking
- Excellent communication and interpersonal skills with inherent ability for negotiation and adjustment
- Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
- We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, nat