PRINCIPAL BIOSTATISTICIAN/SENIOR PRINCIPAL BIOSTATISTICIAN

<p><strong>Position Summary: </strong></p> <p>Provides statistical leadership and support for all phases of clinical development. Specific responsibilities include consulting with clients regarding clinical trial study design and regulatory strategy, writing and reviewing statistical methods and sample size sections of protocols, writing and reviewing statistical analysis plans of complex study designs, reviewing statistical analyses and presenting statistical results. Lead complex programs such as NDA/BLA/MAA submissions or complex, multi-protocol programs and provide statistical oversight. Serve as a subject matter expert for one or more areas (e.g., Bayesian adaptive study design, Survival analysis, DMC, submissions)</p> <p><strong>Essential functions</strong> <strong>of the job include but are not limited to:</strong></p> <ul> <li>Consult with clients regarding clinical trial study design and regulatory strategy</li> <li>Develop and review statistical methods of clinical study protocols</li> <li>Provide and/or verify sample size calculations</li> <li>Author statistical analysis plans of complex study design</li> <li>Review statistical analysis plans written by other biostatisticians</li> <li>Review statistical output to ensure accuracy</li> <li>Review statistical sections of clinical study reports</li> <li>Generate and/or verify randomization schedules</li> <li>Provide statistical analysis and reporting to Data Monitoring Committees (DMCs) as the unblinded reporting biostatistician</li> <li>Work proactively with sponsors, internal study team, and external vendors</li> <li>Serve as a Subject Matter Expert (SME) and develop/review procedural documents and work on new initiatives</li> <li>Provide mentoring and training to other statisticians</li> <li>Attend bid defense meetings for complex programs</li> <li>Other duties as assigned</li> </ul> <p><strong>Qualifications: </strong></p> <p><span style="text-decoration: underline;">Minimum Required:</span></p> <ul> <li>Senior Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 12+ years of experience; PhD degree in Statistics, Biostatistics, or related field with 9+ years of experience</li> <li>Principal Biostatistician level: Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience</li> </ul> <p><span style="text-decoration: underline;">Other Required:</span></p> <ul> <li>Broad experience with regulatory submissions</li> <li>Extensive experience consulting with clients regarding clinical trial study design and regulatory strategy</li> <li>Superior understanding of a statistical methodology (e.g., Bayesian adaptive study design, Survival analysis, Repeated measures)</li> <li>Sound knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines</li> <li>Experience with SAS</li> </ul> <p><span style="text-decoration: underline;">Preferred:</span></p> <ul> <li>Experience with oncology and rare diseases</li> <li>Experience with DMCs</li> <li>Excellent communication and interpersonal skills</li> <li>Excellent problem-solving skills</li> <li>Excellent presentation skills</li> <li>Excellent organizational and time management skills</li> <li>Outstanding statistical skills</li> </ul> <p><strong>Competencies: </strong></p> <ul> <li>Sound judgment/decision making</li> <li>Ability to establish and teach others to maintain effective working relationships with coworkers, managers, and clients</li> <li>Service oriented, accountable, and flexible</li> <li>Competency in written and spoken English</li> <li>Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures</li> <li>At all times to promote the image of Precision, acting as an ambassador to the Company</li> <li>Ensure that all internal systems are routinely updated as appropriate (e.g., timesheets, expense reports, financial reports, etc.) </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description">Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.</div><div class="title">Reasonable estimate of the current range</div><div class="pay-range"><span>$147,300</span><span class="divider">-</span><span>$243,000 USD</span></div></div></div><div class="content-conclusion"><hr> <p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&amp;reserved=0">Privacy Policy.</a> For CA applicants, please also refer to our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&amp;reserved=0">CA Privacy Notice</a>.</p> <p>Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p> <p>If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at <a href="mailto:myHR@precisionmedicinegrp.com">myHR@precisionmedicinegrp.com</a>.</p> <p><span data-teams="true"><strong>Recruitment Fraud Warning: </strong>Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at <a id="menur2oq" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="mailto:myHR@precisionmedicinegrp.com" target="_blank">myHR@precisionmedicinegrp.com</a> so we can investigate and take appropriate action.</span></p></div>