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AltasciencesAL

Senior Biostatistician

Altasciences is a contract research organization specializing in early-phase drug development services to support biopharmaceutical companies.

Altasciences

Employee count: 501-1000

Salary: 80k-110k USD

United States only

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By clicking the Accept button, you agree to us doing so.Learn more:Senior Biostatistician page is loaded## Senior Biostatisticianremote type: Remotelocations: Overland Park, Kansastime type: Full timeposted on: Posted Yesterdayjob requisition id: R **Your New Company!** At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.We are better together and together We Are Altasciences.**About The Role** The Senior Biostatistician is responsible for having expert knowledge of all related processes with the ability to independently lead a study, support analysis, and provide high-quality documents to support sponsors' research programs, , and deliver a high level of quality and timeliness, resulting in high levels of client satisfaction.**What You’ll Do Here** • Follow department and company standard operating procedures (SOPs), forms, templates and policies. • Act as Lead Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team and the client. • Mentor, guide, and train other Biostatisticians in all aspects of the Lead Biostatistician role and all other tasks. • Provide input for Biostatistics portion of project timelines. • Review and provide statistical guidance for protocols for simple to complex studies. • Create and provide Biostatistics-related training to create and sustain culture of continuous improvement. • Generate randomization schedules using SAS or randomization-specific software. • Develop and quality control (QC) review statistical analysis for simple to complex studies. • Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells for studies of simple to moderate complexity. • Develop tables of summary statistics and graphics for clinical aspects of clinical trials.• Develop Inferential Statistics.• Potentially support some Statistical Analysis for our Preclinical group.• Provide statistical analysis for PD subjective measures and PK endpoints. • Responsible for answering deficiency letters from regulatory agencies, as required. • Validate Biostatistician programs and results using SAS. • Perform QC review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure. • Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines. • May represent Biostatistics in client and inter-departmental meetings. • Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines. • Maintain familiarity with client and internal team expectations and produce analyses and documents consistent with these. • Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate (TPD), FDA, European Medicines Agency (EMA), etc) as well as ICH and GCP procedures. • May lead or participate in departmental or interdepartmental quality improvement initiatives. • Maintain and participate in the objectives of the department. • Oversee direct reports as assigned.**What You’ll Need to Succeed** • Bachelor's Degree or higher in Statistics or related field. • Excellent verbal and written communication skills. • Professional attitude and strong interpersonal skills. • Ability to work well with a multi-disciplinary team of professionals. • Client-focused approach to work. • Flexible attitude with respect to work assignments and new learning. • Ability to prioritize workload. • Superior attention to detail. • Understanding of clinical research project life cycle and applicable regulatory guidelines. • Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to information technology (IT) systems as needed. • Excellent SAS programming proficiency.Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Senior Biostatistician including, but not limited to, for the following reasons:* The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.* The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.* The employee frequently communicates with English-only customers outside the province of Quebec.**What We Offer** The salary range estimated for this position is $80,000 - $110,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.**Altasciences' Benefits Package Includes:*** Health/Dental/Vision Insurance Plans* 401(k)/RRSP with Employer Match* Paid Vacation and Holidays* Paid Sick and Bereavement Leave* Employee Assistance & Telehealth Programs**Altasciences' Incentive Programs Include:*** Training & Development Programs* Employee Referral Bonus Program* Annual Performance Review IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH**Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
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About the job

Apply before

Posted on

Job type

Full Time

Experience level

Senior

Salary

Salary: 80k-110k USD

Location requirements

United States

Hiring timezones

United States +/- 0 hours

Job categories

BiologyBiotech & ChemistrySenior BiostatisticianSenior Principal BiostatisticianSenior Manager Of BiostatisticsSenior StatisticianLead BiostatisticianPrincipal BiostatisticianSenior Director Clinical StatisticsHead Of BiostatisticsBiostatistics Manager

Skills

SASSAS ProgrammingRandomization ScheduleRandomization SoftwareTFL ShellsQuality Control (QC)Microsoft WordMicrosoft ExcelBiostatisticsClinical TrialsGood Clinical Practice (GCP)FDAEMAMatter

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About Altasciences

Learn more about Altasciences and their company culture.

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At the heart of what we do is a culture of collaboration and innovation. Altasciences operates as a forward-thinking, mid-size early phase contract research organization based in Canada and the U.S. For over 30 years, we have been reimagining how biotech, biopharma, and pharma companies outsource their early-phase drug development. Our mission is to streamline the drug development process, allowing our clients to focus on their core research while we handle the intricacies of moving a molecule from preclinical phases through to Phase II and beyond.

Our team functions as a flexible and attentive extension to our clients, offering comprehensive services that range from preclinical safety testing to clinical pharmacology trials. We pride ourselves on our proven, flexible approach, ensuring that we tailor our services to meet the specific needs of each biopharmaceutical company we partner with. We understand that in the fast-paced world of drug development, timing can make a huge difference—by leveraging our integrated services, clients can experience up to 40% savings in program durations. We believe in creating a true partnership through solid communication and exceptional science, dedicated to getting better drugs to the patients who need them, faster.

Claim this profileAltasciences logoAL

Altasciences

Company size

501-1000 employees

Founded in

1994

Chief executive officer

Chris Perkin

Markets

Contract Research Organization (CRO)BiotechnologyDrug DevelopmentClinical TrialsPreclinical ResearchMedical ResearchHealthcare ServicesLife SciencesBiopharmaceuticalPharmaceutical

Employees live in

Canada
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